BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2747612 · Received September 17, 2012

    Report

    Report Number
    3007566237-2012-02238
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Report Date
    August 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A51, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT#: V061739, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT#: V000638, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE POWER-ON-RESET (POR) CONDITION WAS DUE TO PATIENT ERROR. IT WAS STATED THAT THE PATIENT "BECOMING MORE COGNITIVELY CHALLENGED" WAS THE RESULT OF DISEASE PROGRESSION. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY DUE TO ASSISTANCE FROM A CARE GIVER. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) INDICATED A POWER-ON-RESET (POR) CONDITION. AN END-OF-SERVICE (EOS) CONDITION MAY HAVE BEEN SEEN, BUT COULD NOT BE CONFIRMED. THE PATIENT HAD LET HIS BATTERY DIE BUT WASN'T "CLOSE ENOUGH TO [THE] TIME WHEN [THE INS] SHOULD BE IN OVERDISCHARGE." THE INS RECHARGER (INSR) INDICATED THAT THE BATTER WAS REALLY LOW. THERE WERE COUPLING AND/OR COMMUNICATION ISSUES. THE POR TYPE WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT WAS BECOMING MORE COGNITIVELY CHALLENGED AND WASN'T ABLE TO BE RESPONSIBLE IN CHARGING HIS DEVICE; HE HAD ASKED HIS WIFE TO START TAKING CHARGE OF IT. A POR RESET WORKED WITH THE PATIENT'S INS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED COUPLING AND/OR COMMUNICATION ISSUES. NO COUPLING BARS WERE SEEN ON THE INSR RECHARGING SCREEN. FURTHER INVESTIGATION REVEALED THAT THE "INS FULL" SCREEN WAS SEEN, INDICATING THAT THE INS BATTERY WAS COMPLETELY FULL. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1