BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3883297 · Received June 19, 2014

    Report

    Report Number
    3007566237-2014-01713
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY WAS FOUND TO BE DEPLETED. DESTRUCTIVE ANALYSIS OF THE BATTERY SHOWED NO INTERNAL FAILURE MECHANISMS AND IT HAD AN INTERNAL CONDITION THAT WAS SIMILAR TO A NORMALLY DISCHARGED CELL. NO ELECTRICAL ANOMALIES WERE FOUND WITH THE HYBRID CIRCUIT AND IT PASSED FUNCTIONAL TESTING WITH AN EXTERNAL POWER SUPPLY AND KNOWN GOOD BATTERY. THE IMPLANT AND EXPLANT DATES ARE NOT GIVEN, HOWEVER, THE INS WAS MANUFACTURED IN JUNE 2008 SO IT IS LIKELY THAT THIS DEVICE HAS BEEN IMPLANTED ABOUT 5 YEARS. NO PARAMETER INFORMATION WAS GIVEN SO THE EXPECTED LIFE COULD NOT BE DETERMINED. BASED ON THE ANALYSIS OF THE INS, THIS DEVICE REACHED A NORMAL END-OF-LIFE CONDITION.

    Description of Event or Problem · 1

    APPROXIMATELY A WEEK AFTER THE LAST REPORT, IT WAS INDICATED THAT THE PATIENT WAS DOING WELL AND RECEIVING THERAPY FOLLOWING THE EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EXPLANT HAD TAKEN PLACE. PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED AN IMMEDIATE RETURN OF THEIR TREMOR SYMPTOMS FOLLOWING BEING SHOCKED BY AN ELECTRIC FENCE. IT WAS STATED THE PATIENT THEN ATTEMPTED TO TURN THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ON WITH THEIR PATIENT PROGRAMMER AND COULDN¿T. IT WAS NOTED THERE WAS NO COMMUNICATION BETWEEN THE INS AND A PHYSICIAN PROGRAMMER THE DAY PRIOR TO REPORT. IT WAS REPORTED THE SHOCK FROM THE ELECTRIC FENCE ¿SEEMED TO HAVE DAMAGED THE BATTERY¿ AND THAT THE INS WAS ¿NO LONGER WORKING.¿ IT WAS STATED THAT AN INS REPLACEMENT WAS TO BE PLANNED. IT WAS NOTED THE PATIENT WAS OTHERWISE ALIVE WITH NO INJURY AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE BATTERY COULD STILL NOT BE SWITCHED BACK ON EVEN AFTER AN ATTEMPT WAS MADE USING A MAGNET. THE PATIENT WAS NOT RECEIVING THERAPY. THE EXPLANT WAS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361603 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention