SURESCAN
Report
- Report Number
- 3004209178-2019-00036
- Event Type
- Malfunction
- Date Received
- January 2, 2019
- Date of Event
- December 27, 2018
- Report Date
- February 27, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109483
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONTINUATION OF D11: PRODUCT ID 977A290, SERIAL#: (B)(4), PRODUCT TYPE: LEAD; PRODUCT ID 977A290, SERIAL#: (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL#: (B)(4), PRODUCT TYPE: LEAD PRODUCT ID 977A260, SERIAL#: (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE: LEAD; PRODUCT ID 97714, SERIAL#: (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.
CONTINUATION OF D11: PRODUCT ID 977A290 SERIAL# (B)(4) PRODUCT TYPE LEAD. PRODUCT ID 977A290 SERIAL# (B)(4) PRODUCT TYPE LEAD. PRODUCT ID 977A260 SERIAL# (B)(4) PRODUCT TYPE LEAD. PRODUCT ID 977A260 SERIAL# (B)(4) PRODUCT TYPE LEAD. PRODUCT ID 97714 SERIAL# (B)(4) PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. 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.
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.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE ON CONTACT 1 AND CONTACT 8. IT WAS NOTED THAT THIS WAS DISCOVERED DURING A DOUBLE BATTERY REPLACEMENT. THE REP REPORTED THAT THE PATIENT DENIED FALLS OR TRAUMAS. THE REP REPORTED THAT THE HEALTHCARE PROVIDER (HCP) OBTAINED X-RAYS PRIOR TO THE BATTERY REPLACEMENT AND SAID IT LOOKED LIKE THE PATIENT HAD FRACTURED HIS CERVICAL LEADS. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WASN¿T DETERMINED. THE REP REPORTED THAT THE PATIENT DENIED TRAUMA TO CAUSE A BREAK IN THE LEADS. THE PATIENT HAD A FOLLOW UP APPOINTMENT ON (B)(6) 2019. THE REP REPORTED THAT NO INTERVENTIONS WERE TAKEN SO FAR. THE IMPEDANCES WERE DISCOVERED WHEN THE PATIENT HAD SURGERY. THE REP WAS UNABLE TO ASK THE PATIENT TO CHANGE POSITIONS TO SEE IF THE IMPEDANCES RESOLVED. THE REP WAS TO CHECK THE IMPEDANCES AT THE FOLLOW UP APPOINTMENT. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE OF THE LEAD FRACTURE WAS NOT DETERMINED. THE REP SAID AN X-RAY WAS COMPLETED ON (B)(6) 2018 TO CONFIRM THE FRACTURE. THE REP STATED THAT THE SERIAL NUMBER OF THE LEAD WAS UNKNOWN AND THE LEAD FRACTURE HAD NOT BEEN RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.
CONCOMITANT MEDICAL PRODUCTS: OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 977A290, SERIAL#: (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 977A290, SERIAL#: (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL#: (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL#: (B)(4), PRODUCT TYPE: LEAD. REFER TO MANUFACTURER REPORT #3004209178-2019-00033 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH TWO IMPLANTABLE NEUROSTIMULATORS (INS) FOR THE TREATMENT OF SPINAL PAIN AND COMPLEX REG PAIN SYNDROME TYPE I. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE RECEIVED AN X-RAY AND IT APPEARED THAT ONE OF THE PATIENT¿S LEADS WAS FRACTURED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT RECENTLY HAD A FOLLOW UP VISIT WHERE IT WAS OBSERVED THAT THE IMPENDENCES WERE STILL PRESENT ON CONTACT 8, BUT RESOLVED ON CONTACT 1. THE REP SAID NO NEW IMPEDANCES WERE FOUND. THE REP STATED THAT SINCE THE PATIENT HAD NEW INS BATTERIES PLACED, THE SYSTEMS WERE LEFT OFF FOR 2 WEEKS UNTIL THE RECENT POST OP VISIT. THE PATIENT WAS PROGRAMMED AND, THE REP SAID TO THE BEST OF THEIR KNOWLEDGE, THERE WERE NO COMPLAINTS AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1974 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |