ACTIVA
Report
- Report Number
- 3004209178-2017-10590
- Event Type
- Malfunction
- Date Received
- May 18, 2017
- Date of Event
- May 16, 2017
- Report Date
- December 21, 2017
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169529786
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
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.
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387-40, LOT# VA00FZE, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V727699, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4). 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.
ANALYSIS OF THE EXTENSION (SERIAL NO. (B)94)) FOUND THAT THE PROXIMAL END CONNECTOR WAS NOT COMPLETELY SEATED IN THE INS CONNECTOR PORT. ANALYSIS OF THE EXTENSION (SERIAL NO. (B)(4)) FOUND THAT THE CONDUCTOR WAS BROKEN LESS THAN 5 CM FROM THE PROXIMAL END AND THE PROXIMAL END CONNECTOR WAS NOT COMPLETELY SEATED IN THE INS PORT. ANALYSIS INFORMATION -- 2017-11-09 21:36:44 CST PLI# 20 PRODUCT ID# 3708640 BELOW IS UNEDITED, SYSTEM GENERATED TEXT BASED ON THE ANALYSIS FINDING CODE(S) AND TEST RESULTS. ELECTRICAL TESTING OF THE EXTENSION DETERMINED THAT CONTINUITY WAS COMPLETE AND THERE WERE NO ELECTRICAL SHORTS BETWEEN THE CIRCUITS; HOWEVER, THE EXTENSION WAS NOT COMPLETELY SEATED IN THE IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR PORT. ELECTRICAL TESTING OF THE EXTENSION DETERMINED CONTINUITY WAS COMPLETE AND NO ELECTRICAL SHORTS WERE IDENTIFIED BETWEEN THE CIRCUITS. ANALYSIS IDENTIFIED THE OUTER INSULATION OF THE EXTENSION WAS {BROKEN//TORN} UNDER THE {UNDER CONNECTOR #0 AT 2.1 CM FROM THE PROXIMAL END.} CONNECTOR. ANALYSIS DETERMINED THE SETSCREW IMPRESSION WAS NOT IN THE CORRECT LOCATION. ANALYSIS INFORMATION -- 2017-11-13 21:12:07 CST PLI# 30 PRODUCT ID# 37085-40 BELOW IS UNEDITED, SYSTEM GENERATED TEXT BASED ON THE ANALYSIS FINDING CODE(S) AND TEST RESULTS. ANALYSIS IDENTIFIED THAT THE {X} CONDUCTOR(S) WAS/WERE BROKEN IN THE BODY OF THE EXTENSION {X} CM FROM THE PROXIMAL END. ELECTRICAL TESTING OF THE EXTENSION DETERMINED THAT CONTINUITY WAS COMPLETE AND THERE WERE NO ELECTRICAL SHORTS BETWEEN THE CIRCUITS; HOWEVER, THE EXTENSION WAS NOT COMPLETELY SEATED IN THE IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR PORT. ELECTRICAL TESTING OF THE EXTENSION DETERMINED CONTINUITY WAS COMPLETE AND NO ELECTRICAL SHORTS WERE IDENTIFIED BETWEEN THE CIRCUITS. SETSCREW IMPRESSIONS WERE OBSERVED IN THE INSULATION ON THE PROXIMAL END OF THE EXTENSION. {ON THE INSULATION BETWEEN CONNECTOR #1 AND CONNECTOR #2.} ANALYSIS DETERMINED THE SETSCREW IMPRESSION WAS NOT IN THE CORRECT LOCATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (B)(6) REVEALED THERE WAS NO FAILURE DETECTED, THE DEVICE OPERATED WITHIN SPECIFICATION. CONTINUATION OF: PRODUCT ID 37601 (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. THE REP REPORTED THAT HIGH IMPEDANCES WERE MEASURED ON THE PATIENT'S INS DURING AN UNRELATED PROCEDURE. THE REP REPORTED THAT THE LEFT HEMISPHERE ELECTRODE IMPEDANCES WERE MEASURED AT 3.0V AND FOUND TO BE: C <(>&<)> 3: 13151 OHMS 0 <(>&<)> 3: 14494 OHMS 1 <(>&<)> 3: 14427 OHMS 2 <(>&<)> 3: 14360 OHMS WHILE THE RIGHT HEMISPHERE ELECTRODE IMPEDANCES WERE MEASURED AT 3.0V AND FOUND TO BE: C <(>&<)> 9 >40000 C <(>&<)> 10 >40000 C <(>&<)> 11 >40000 8 <(>&<)> 9 >40000 8 <(>&<)> 10 >40000 8 <(>&<)> 11 >40000 9 <(>&<)> 10 >40000 9 <(>&<)> 11 >40000 10 <(>&<)> 11 >40000 THE REP REPORTED THAT THE HEALTHCARE PROVIDER (HCP) BEGAN TROUBLESHOOTING BY CLEANING OFF THE EXTENSIONS AND VISUALLY INSPECTING THE HEADER BLOCK. THE HCP THEN REVERSED THE EXTENSIONS IN THE PORTS AND RAN ANOTHER IMPEDANCE CHECK WITH NO CHANGE. THE REP REPORTED THAT THE HCP TRIED REINSERTING THE EXTENSIONS MULTIPLE TIMES AND RAN MULTIPLE IMPEDANCE CHECKS. THE REP REPORTED THAT A NEW INS WAS OPENED AND CONNECTED. THE REP REPORTED AN IMPEDANCE CHECK WAS RUN FOR BOTH HEMISPHERES AT 3.0V AND ALL ELECTRODE COMBINATIONS WERE MEASURED AT >40 ,000 OHMS. THE SAME TROUBLESHOOTING STEPS WERE FOLLOWED FOR THE NEW INS WITH NO CHANGE. THE NEW INS WAS LEFT IMPLANTED AND A POST-OP IMPEDANCE CHECK WAS RUN AT 1.5V FOR THE LEFT HEMISPHERE AND 3.0V FOR THE RIGHT, WITH IMPEDANCE MEASUREMENTS OF >20,000 OHMS AND >40,000 OHMS RESPECTIVELY. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HCP VIA THE REP REPORTING THAT THE PATIENT WAS SENT BACK TO THE NEUROLOGIST FOR FURTHER REVIEW. THE REP REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCE REMAINED UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
AN HCP VIA THE REP REPORTED THAT THE REPLACEMENT PROCEDURE WAS FOR ROUTINE BATTERY DEPLETION. THE CAUSE OF THE HIGH IMPEDANCES WERE STILL UNKNOWN AND REMAINED UNRESOLVED.
NO ADDITIONAL INFORMATION WAS RECEIVED.
ADDITIONAL INFORMATION WAS RECEIVED FROM HCP. THE CAUSE REMAINED UNKNOWN. THE PATIENT WAS REFERRED BACK TO THE DOCTOR THAT PLACED THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358256 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37601 | 00643169529786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |