BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3864263 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11296
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-1525-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE ¿INS HAD THE EOS BIT RESET TO TEST OUTPUT. OUTPUT WAS GOOD. BATTERY VOLTAGE WAS AT END OF SERVICE (EOS). DESTRUCTIVE ANALYSIS OF THE INS SHOWED NO ANOMALY FOUND WITH THE INS HYBRID. THE INS HYBRID HAD A CURRENT DRAIN TO TEST THE HYBRID FUNCTION. NO ANOMALIES SEEN. NGT TESTING DONE WITH ORIGINAL BATTERY PRIOR TO DESTRUCTIVE ANALYSIS. NGT FAILED DUE TO BATTERY AT EOS. INS BATTERY WAS SENT FOR FURTHER ANALYSIS. DESTRUCTIVE ANALYSIS OF THE INS BATTERY SHOWED NORMAL DEPLETION WITH NO INTERNAL SHORTING PATH OR UN-ATTRIBUTABLE DAMAGE TO ANY OF THE CELL COMPONENTS AND INDICATE NO ISSUES WITH BATTERY PERFORMANCE.¿ THE INS HAD REACHED EOS WITH AN ¿UNKNOWN CAUSE¿ FOR THE LONGEVITY NOT BEING MET.

    Additional Manufacturer Narrative · 1

    THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED TO A HIGH CYCLING MODE OF 0.1 SEC ON AND 0.1 SEC OFF. DUE TO THE HIGH CYCLING, THIS MAY NEGATIVELY AFFECT BATTERY LIFE AND LONGEVITY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) EXPERIENCED ¿PREMATURE¿ BATTERY DEPLETION. IT WAS STATED THAT AS A RESULT OF THIS, THE INS WAS EXPLANTED AND REPLACED SIX DAYS PRIOR TO REPORT. IT WAS NOTED THE PATIENT¿S INS HAD THERAPEUTIC IMPEDANCES OF 1544 OHMS WHEN PROGRAMMED WITH ELECTRODES 2+ AND 3- AT 160 HZ, 3.05 VOLTS, AND 60 MICROSECONDS. IT WAS STATED THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338589 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention