ACTIVA
Report
- Report Number
- 3004209178-2019-23686
- Event Type
- Malfunction
- Date Received
- December 12, 2019
- Date of Event
- December 8, 2019
- Report Date
- April 1, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169864238
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF THE LEAD (LOT #V884064) FOUND THE PROXIMAL END CONNECTOR PULLED OFF. ANALYSIS OF THE EXTENSION (SERIAL #(B)(6) FOUND THE BODY PRODUCT SEGMENTED. 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.
D11: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37085-60, SERIAL# (B)(6), PRODUCT TYPE: EXTENSION. H3: ANALYSIS RESULTS FOR THE EXTENSION (SERIAL # (B)(6)) WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. 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.
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'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) . IT WAS REPORTED THAT PATIENT WAS AT THEIR COMPUTER ON SUNDAY AND FELT A SHOCK ON THE LEFT SIDE OF THE BODY UP AND DOWN. THE PATIENT THEN FELT IT AGAIN WHILE SITTING ON THE COUCH. IT WAS STATED THAT THE PATIENT TAKES A BOXING CLASS FOR PARKINSON'S PATIENTS BUT THAT CLASS WAS TODAY, NOT DURING THE TIME OF THE SHOCKING. IT WAS REPORTED THAT ALL IMPEDANCES ON THE LEFT SIDE WERE NORMAL, EVEN WHEN TURNING THEIR HEAD FROM SIDE TO SIDE. PATIENT DID FEEL THE SENSATION AGAIN WHEN TURNING THEIR HEAD THE LEFT, AND ALSO FELT IT WHEN THEIR WIFE WAS PALPATING THE SYSTEM AND GOT TO THE INS/EXTENSION POINT. THE REP WILL DISCUSS WITH THE HEALTH CARE PROVIDER (HCP) ABOUT OBTAINING IMAGING OR REPROGRAMMING. IT WAS NOTED THAT THE VENT WAS FOR THE LEFT SIDE BATTERY, THERAPY ON THE RIGHT SIDE OF THE BODY WAS OK. THE REP CHECKED IMPEDANCES ON THE RIGHT SIDE, DUE TO THE PATIENT GETTING SHOCKING AND VALUES WITH CONTACT 1 WITH OUT OF RANGE. C & 1 11.6K, 3 & 1 12.0K, 2 & 1 10.5K, 1 & 0 10.4K . CONTACT 1 IS USED IN PROGRAMMING. PATIENT WAS PROGRAMMED WITH CONSTANT VOLTAGE.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE CAUSE OF THE OUT OF RANGE IMPEDANCES ON CONTACT 1 WAS NOT DETERMINED. IT WAS STATED THAT ON (B)(6) 2019, THE PATIENT SAW A NEW NEUROLOGIST WHO ADJUSTED THE RIGHT SIDE SYSTEM. THE NEUROLOGIST CHANGED THE NEGATIVE CONTACT FROM 1 TO CONTACT 2, WHICH ELIMINATED THE SHOCKING SENSATIONS THAT THE PATIENT WAS EXPERIENCING AND THE TREMORS WERE ALLEVIATED AS WELL. AN X-RAY WAS TAKEN ON (B)(6) 2019, BUT THE NEUROLOGIST DID NOT HAVE ACCESS TO READ IT AT THE APPOINTMENT. THEY WILL REVIEW IT AT THE NEXT APPOINTMENT. THE SHOCKING HAD BEEN RESOLVED BECAUSE THE ACTIVE CONTACT WAS CHANGED FROM #1 TO #2. THE NUMBER 1 CONTACT WAS THE ONE SHOWING AN OPEN CIRCUIT ON (B)(6) AND AGAIN (B)(6), SO THE OUT OF RANGE IMPEDANCE REMAINS ON CONTACT 1, BUT IT WAS NOT BEING FOR THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1253616 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 | 00643169864238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |