BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2656801 · Received July 16, 2012

    Report

    Report Number
    3004209178-2012-05663
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Report Date
    June 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD, MODEL 3387S-40, LOT# V011938, IMPLANTED: (B)(6) 2007, EXPLANTED: NA. LEAD, MODEL 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007, EXPLANTED: NA. EXTENSION, MODEL 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. EXTENSION, MODEL 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PROGRAMMER, MODEL 37642, SERIAL# (B)(4). RECHARGER, MODEL 37651, SERIAL# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT'S FOLLOW-UP PHYSICIAN WAS NOT AWARE OF THE EVENT AND HAD NO FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED COUPLING AND OR COMMUNICATION ISSUES AFTER RECEIVING A NEW NEUROSTIMULATOR ON (B)(6). THE PATIENT WAS UNABLE TO GET HARDLY ANY COUPLING BARS UNTIL (B)(6). THE INS WAS ALMOST COMPLETELY DEPLETED, DESPITE HAVING BEEN FULLY CHARGED ON THE DAY OF IMPLANT. IT WAS NOTED THAT PRIOR TO THE INS REPLACEMENT, THE REPORTER WAS AWARE OF A SHORT ON ONE OF THE LEADS (SEE MFR. REP. # 3004209178-2011-03805 AND 3004209178-2011-05167). IT WAS ALSO REPORTED THAT STIMULATION WAS OFF, AND THEY HAD NOT BEEN ABLE TO TURN IT ON, SINCE SURGERY WITH THE PATIENT PROGRAMMER OR THE RECHARGER, AND THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS ALSO REPORTED THAT STIMULATION WAS TURNED OFF TO PRESERVE BATTERY, BUT THE PATIENT WAS STILL NOT EXPERIENCING A FULL RETURN OF SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 37612

    Patients

    Seq Age Sex Outcome Treatment
    1