HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2017-03799
- Event Type
- Malfunction
- Date Received
- October 23, 2017
- Date of Event
- September 8, 2017
- Report Date
- August 26, 2019
- Manufacturer
- HEARTWARE
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018; Z-0067-2019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
(B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE REPORTED EVENT WAS CONFIRMED VIA LOG FILE ANALYSIS. THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. D4: (B)(4) - BATTERY. D10: YES, 2017-10-23 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H6: RESULT CODE(S): 3233 H6: CONCLUSION CODE(S): 11 THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. D4: (B)(4) - BATTERY D10: YES, 2017-10-23 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H6: RESULT CODE(S): 3233 H6: CONCLUSION CODE(S): 11 THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. D4: (B)(4) - BATTERY D10: YES, 2017-10-23 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H6: RESULT CODE(S): 3233 H6: CONCLUSION CODE(S): 11 THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. D4: (B)(4) - BATTERY D10: YES, 2017-10-24 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H6: RESULT CODE(S): 3233 H6: CONCLUSION CODE(S): 11 D4: (B)(4)- BATTERY D10: YES, 2017-10-24 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H6: RESULT CODE(S): 3233 H6: CONCLUSION CODE(S): 11 THIS REPORT WAS IDENTIFIED FOLLOWING THE CONVERSION OF COMPLAINT FILES FROM THE LEGACY COMPLAINT HANDLING SYSTEM FOLLOWING INTEGRATION AND IS BEING SUBMITTED TO REPORT ANALYSIS RESULTS. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE CONTROLLER (CON301010) AND FIVE BATTERIES (BAT221504, BAT221043, BAT221417, BAT221373 AND BAT221074) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE UNIT PASSED FUNCTIONAL TESTING; VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS SURROUNDING POWER PORT TWO (2). AN INTERNAL VISUAL INSPECTION DID NOT REVEAL FLUID INGRESS. THE HAIRLINE CRACKS ARE NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT221504, BAT221043, BAT221373, AND BAT221074. ADDITIONALLY, POWER SWITCHING EVENTS WERE RECORDED DUE TO COMMUNICATION ERRORS INVOLVING BAT221504, BAT221043, BAT221417, AND BAT221074. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS MOMENTARY DISCONNECTIONS. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY: THE CONTROLLER ((B)(4)) AND FIVE BATTERIES ((B)(4)) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). ADDITIONALLY, POWER SWITCHING EVENTS WERE RECORDED DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS OPEN TO EVALUATE MOMENTARY DISCONNECTIONS. (B)(4). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY: ONE CONTROLLER ((B)(6) ) AND FIVE BATTERIES ((B)(6) ) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE UNIT PASSED FUNCTIONAL TESTING; VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS SURROUNDING POWER PORT TWO. AN INTERNAL VISUAL INSPECTION DID NOT REVEAL FLUID INGRESS. THE HAIRLINE CRACKS ARE NOT RELATED TO THE REPORTED EVENT. BASED ON AN INTERNAL INVESTIGATION CONDUCTED, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, CON301010, CONTAINED A SOFTWARE FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6) . ADDITIONALLY, POWER SWITCHING EVENTS WERE RECORDED DUE TO COMMUNICATION ERRORS INVOLVING (B)(6) . DATA LOG FILES ALSO REVEALED MULTIPLE INSTANCES INVOLVING (B)(6) WHERE THE BATTERIES¿ RELATIVE STATE OF CHARGE (RSOC) WAS BETWEEN 101-201, WHICH ARE INDICATIVE OF COMMUNICA TION ERRORS. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILES REVEALED MULTIPLE CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS INVOLVING (B)(6) WITHIN THE ANALYZED PERIOD. ANALYSIS OF THE ALARM LOGS FILES ALSO REVEALED MULTIPLE CRITICAL BATTERY ALARMS INVOLVING (B)(6) DUE TO THE BATTERIES DEPLETING TO 10% RELATIVE STATE OF CHARGE (RSOC). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES AND THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10%. POSSIBLE ROOT CAUSES OF THE REPORTED COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERY, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. AN INTERNAL INVESTIGATION EXAMINED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D4: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-AUG-2017 / SERIAL#: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 23-OCT-2017 H3: YES DEV RTN TO MFR? YES H4: MFG DATE: 31-AUG-2016 H5: NO H6: PATIENT CODE(S): C50675 H6: DEVICE CODE(S): C63030 H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 19 D4: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-JUL-2017 / SERIAL#: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 23-OCT-2017 H3: YES DEV RTN TO MFR? YES H4: MFG DATE: 09-JUL-2016 H5: NO H6: PATIENT CODE(S): C50675 H6: DEVICE CODE(S): C63030 H6: FDA METHOD CODE(S): 10, 4112 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 19 D4: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-JUL-2017 / SERIAL#: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 23-OCT-2017 H3: YES DEV RTN TO MFR? YES H4: MFG DATE: 22-JUL-2016 H5: NO H6: PATIENT CODE(S): C50675 H6: DEVICE CODE(S): C63030 H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 19, 4307 D4: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-JUL-2017 / SERIAL#: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 24-OCT-2017 H3: YES DEV RTN TO MFR? YES H4: MFG DATE: 21-JUL-2016 H5: NO H6: PATIENT CODE(S): C50675 H6: DEVICE CODE(S): C63030 H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 12, 19 D4: MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-JUL-2017 / SERIAL#: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 24-OCT-2017 H3: YES DEV RTN TO MFR? YES H4: MFG DATE: 13-JUL-2017 H5: NO H6: PATIENT CODE(S): C50675 H6: DEVICE CODE(S): C63030 H6: FDA METHOD CODE(S): 4112 H6: FDA CONCLUSION CODE(S): 19 THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
LOG FILE REVIEW INDICATED THAT ONE BATTERY EXHIBITED A CRITICAL BATTERY ALARM AND FOUR OF THE BATTERIES ALSO HAD COMMUNICATION ERRORS.
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. BRAND NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 08/31/2017. NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. (B)(4). BRAND NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 07/31/2017 NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. (B)(4). BRAND NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4). - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 07/31/2017. NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. (B)(4). BRAND NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4). - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 07/31/2017. NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. (B)(4). BRAND NAME: HEARTWARE® VENTRICULAR ASSIST SYSTEM - BATTERY. (B)(4). - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 07/31/2017. NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
BATTERY/ (B)(4). DEVICE EVALUATED BY MANUFACTURER: YES. THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BATTERY/ (B)(4). DEVICE EVALUATED BY MANUFACTURER: YES. THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THERE WAS POWER SWITCHING ON ALL BATTERIES. THE CONTROLLER AND BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 750164 | HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | CIRCULATORY ASSIST SYSTEM | DSQ | HEARTWARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |