BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2182353 · Received July 11, 2011

    Report

    Report Number
    9614453-2011-05296
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF EXTENSION MODEL 37085 SERIAL NUMBER (B)(4) DETERMINED THE EXTENSION WAS OKAY BUT CUT THROUGH (SUSPECTED EXPLANT DAMAGE). THE CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS NO SIGNIFICANT ANOMALIES WERE FOUND. ANALYSIS OF LEAD MODEL LEAD MVD SERIAL NUMBER UNKNOWN DETERMINED ALL THE CONDUCTOR WIRE WERE STRETCHED ON THE RETURNED PROXIMAL SEGMENT. THIS WAS SUSPECT EXPLANT DAMAGE. THE RETURNED PROXIMAL SEGMENT HAS CONTINUITY ACCEPTABLE WITH NO SHORTS. IT WAS UNABLE TO DETERMINE THE SUSPECTED HIGH IMPEDANCE. NO SIGNIFICANT ANOMALY WAS FOUND WITH THE LEAD.

    Description of Event or Problem · 1

    RECEIVED INFO THE PT WAS ADMITTED TO A REHABILITATION CENTER IN EARLY APRIL AND THE PHYSICIAN NOTED BEHAVIORAL SIDE EFFECTS. THE PT WAS SEXUALLY INAPPROPRIATE. THE PHYSICIAN FELT THIS WAS DIRECTLY RELATED TO THE STIMULATION, SO THE DEVICE WAS TURNED OFF. THE BEHAVIORAL CHANGES IMPROVED TWO WEEKS AFTER THE STIMULATOR WAS SWITCHED OFF. THE DEVICE WAS REPROGRAMMED BY THE PHYSICIAN AND HE NOTED UNUSUAL IMPEDANCE READINGS AND REQUESTED THE DEVICE BE INTERROGATED BY A MFR'S REP. INTERROGATION WAS ON (B)(6) 2011 AND READINGS SHOWED ALL ELECTRODES PAIRS USING ELECTRODE 9 WERE NOTED TO HAVE HIGH IMPEDANCES. TEST VALUES WERE INCREASED AND IMPEDANCES REMAINED HIGH ON ELECTRODE 9. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BOOKED FOR EXPLORATORY SURGERY ON (B)(6) 2011 TO ATTEMPT TO RESOLVE THE OUT OF RANGE IMPEDANCE RESULTS. THE PATIENT UNDERWENT A REVISION OPERATION TO DETERMINE THE AND CAUSE OF THE SHORT CIRCUIT BETWEEN ELECTRODE 10 AND 11 AND ELECTRODE 9 HAVING A HIGH IMPEDANCE. THERE WAS A LARGE AMOUNT OF RESISTANCE AND THE LEAD APPEARED TO BE STRETCHING AS THE HCP ATTEMPTED TO REMOVE IT. THE HCP WAS FINALLY ABLE TO REMOVE THE LEAD AND IT APPEARED TO BE BENT AND BROKEN. THE DAMAGED PORTION OF THE LEAD WAS REMOVED. THE EXTENSION WAS ALSO REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC EUROPE SARL 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male