BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2551568 · Received April 27, 2012

    Report

    Report Number
    3004209178-2012-02737
    Event Type
    Injury
    Date Received
    April 27, 2012
    Report Date
    April 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37612, SERIAL # (B)(4) SHOWED GOOD STABLE OUTPUT ON ELECTRODE PAIRS AS RECEIVED. THE LEAD CONFIGURATION IN THE INS WAS PROGRAMMED 2X4 WITH ELECTRODES 0-3 AND 4-7. THE CORRECT CONFIGURATION WAS 2X4 WITH ELECTRODES 0-3 AND 8-11. THE INS WAS PROGRAMMED TO THE LATTER CONFIGURATION AND ALL IMPEDANCES TESTED WERE WITHIN NORMAL RANGE.

    Additional Manufacturer Narrative · 1

    LEAD MODEL: 3387S-40, LOT #: V014191, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; LEAD MODEL: 3387S-40, LOT #: V014191, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; EXTENSION MODEL: 37085-60, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012; PROGRAMMER MODEL: 37642, SERIAL #: (B)(4); RECHARGER MODEL: 37651, SERIAL #: (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES >40000 OHMS WERE MEASURED ON THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOLLOWING A BATTERY REPLACEMENT ON (B)(6) 2012. AFTER REPLACEMENT, IMPEDANCES ON ALL ELECTRODE PAIRS ON THE RIGHT CHANNEL MEASURED >40000 OHMS. AN OPEN CIRCUIT WAS SUSPECTED AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2012. DURING REVISION, THE IMPEDANCES OF THE LEAD WERE WITHIN NORMAL RANGES. THE RIGHT EXTENSION WAS REPLACED AND A NEW ONE WAS CONNECTED TO THE EXISTING LEAD, BUT HIGH IMPEDANCES WERE STILL MEASURED. SWITCHING THE TAILS OF THE EXTENSION AND PLUGGING INTO THE OPPOSITE CONNECTOR PORT OF THE INS DID NOT RESOLVE THE ISSUE. THE INS WAS THEN REPLACED, AFTER WHICH NORMAL IMPEDANCE VALUES WERE MEASURED THROUGHOUT THE SYSTEM. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE AND RECEIVING EFFECTIVE THERAPY.

    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 Required Intervention