BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2862578 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11309
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO SIGNIFICANT ANOMALY. TELEMETRY AND OUTPUT WERE OKAY. THE INS REACHED A NORMAL END-OF-SERVICE CONDITION. A LONGEVITY ESTIMATE BASED ON AN 8840 PARAMETER PRINTOUT RECEIVED WITH THE INS INDICATED THAT THE EXPECTED LIFE WAS 18.39 MONTHS TO ERI AND 21.39 MONTHS TO EOS. BASED ON THE TRACE REPORT TAKEN FROM THE INS, THE BATTERY DEPLETED TO ERI IN 23.3 MONTHS AND REACHED EOS IN 26.7 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERY DEPLETION WAS "NOT NORMAL." IT WAS STATED THAT THE BATTERY ONLY LASTED 2 YEARS. PATIENT WAS UNAWARE THAT END OF SERVICE (EOS) WOULD OCCUR "SO SOON AFTER IMPLANT." EOS CAME UP "VERY QUICKLY", THE BATTERY STOPPED WORKING AND PATIENT SYMPTOMS RETURNED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention