ACTIVA
Report
- Report Number
- 9614453-2013-00553
- Event Type
- Injury
- Date Received
- March 6, 2013
- Report Date
- February 12, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 37085-40, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(6). (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALY FOUND. THE INS WAS RECEIVED WITH THE ERI AND EOS BIT SET. IT IS SUSPECTED THAT A SHORT ACROSS THE #0 TO #3 ELECTRODES (87 OHMS) EXTERNAL TO THE INS CAUSED THE BATTERY TO BE PULLED DOWN TO THE POINT OF SETTING THE ERI AND EOS BITS. ONCE THE EOS BIT WAS SET AND THE OUTPUT SHUT OFF, THE BATTERY WAS ABLE TO RECOVER BACK TO THE 2.98 VOLTS SHOWN ON THE RETURNED PRINTOUT OF (B)(6) 2013. A LONGEVITY ESTIMATE BASED ON THE RETURNED PARAMETER PRINTOUT OF (B)(6) 2012 WAS DONE TO SHOW THE DIFFERENCE BETWEEN THE EXPECTED LIFE (12.34 MONTHS TO ERI, 15.34 MONTHS TO EOS) AND THE REDUCED LIFE CAUSED BY A SHORT (<(><<)>3 MONTHS TO ERI, 4.85 MONTHS TO EOS). THE CAUSE OF THE SHORT BETWEEN THE #0 AND #3 ELECTRODES COULD NOT BE DETERMINED. FINAL DEVICE ANALYSIS OF THE EXTENSION REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALY FOUND. THE EXTENSION HAD A BREACHED MELTED SPOT IN THE OUTER INSULATION. AT THIS LOCATION THE WIRE INSULATION ON THE #1 AND #3 CONDUCTORS WAS ALSO BREACHED. IT IS SUSPECTED THAT THIS WAS EXPLANT DAMAGE, DUE TO CAUTERY, SINCE THE SHORT OBSERVED ON THE RETURNED PRINTOUT WHILE THE DEVICE WAS IMPLANTED WAS BETWEEN THE #0 AND #3 CONDUCTORS. THE EXTENSION HAD GOOD CONTINUITY ON ALL CIRCUITS AND NO SHORTS BETWEEN CIRCUITS WERE IDENTIFIED. THE CAUSE OF THE SHORT OBSERVED ON THE RETURNED PRINTOUT WHILE THE DEVICE WAS IMPLANTED COULD NOT BE DETERMINED.
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION STATED THERE WAS NO ERROR CODE SHOWN DURING THE EXPLANTATION OF THE DEVICE.
FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS DOING OK AFTER THE REPLACEMENT SURGERY. IT WAS NOTED THAT THEIR SYMPTOMS HAD RESOLVED AND THAT THEY WERE RECEIVING EFFECTIVE THERAPY. IN ADDITION, IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH THE NEW DEVICE SYSTEM AFTER THE REPLACEMENT.
IT WAS REPORTED THE PATIENT'S DEVICE WAS EXPLANTED BECAUSE WHEN INTERROGATED AN END OF SERVICE MESSAGE WAS DISPLAYED. IT WAS ALSO RE PORTED THE BATTERY'S VOLTAGE WAS AT 2.9 VOLTS AND THE HEALTHCARE PROVIDER REPORTED AN "ERROR CODE 006." IT WAS ALSO REPORTED THE DEVICE TURNED OFF, COULD NOT BE TURNED BACK ON, AND THE PATIENT HAD A RETURN OF SYMPTOMS. IT WAS REPORTED THE BATTERY WAS REPLACED AND DURING THE REPLACEMENT SURGERY IT WAS NOTED THERE WAS AN INSULATION PROBLEM ON THE EXTENSION IN SOCKET 1 WITH ELECTRODES 0-7. IT WAS ALSO REPORTED THERE WERE LOW IMPEDANCES AT CONTACTS 0 AND 3 AND THE EXTENSION WAS EXPLANTED. IT WAS REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96228 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | IPG MFG SWITZERLAND | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |