BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2821921 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-09981
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 10, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7495-51 LOT# SERIAL# (B)(4), IMPLANTED: 1999 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3387-40 LOT# L73657, IMPLANTED: 1999 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION FOLLOWING A FALL IN THEIR DRIVEWAY. THE SHOCKING WENT DOWN HER RIGHT ARM AND LASTED ABOUT 2 MINUTES. SPECIFICALLY, THE PATIENT FELL TO HER KNEES THEN ONTO THEIR FACE AND POSSIBLY HIT THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS FINE AT FIRST THEN NOTICED THE SHOCKING WHILE CROCHETING, WATCHING TV, AND JUST SITTING. IT WAS NOTED THAT THE SHOCKING OCCURRED MORE AT NIGHT WHILE LYING ON THEIR STOMACH. IMPEDANCE MEASUREMENTS THAT WERE TAKEN WERE NORMAL. PALPATION OF THE INS DID NOT CAUSE ANY STIMULATION CHANGES. THE PATIENT WAS CURRENTLY PROGRAMMED AT CASE+, ELECTRODES 1-, 2-, 2.8 VOLTS, 120 PW, AND 1440 HZ. THERAPY IMPEDANCES WERE MEASURED AT 624 OHMS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR A BAD (UNCLEAR IF IT WAS THE SAME FALL MENTIONED PREVIOUSLY). FOLLOW UP INFORMATION RECEIVED CONFIRMED THAT THE PATIENT'S FALL WAS NOT CAUSED BY THE INS BUT IT WAS REPORTED THAT THE FALL MAY HAVE DAMAGE. TWO ELECTRODES SHOWED "ABNORMAL" IMPEDANCES. X-RAYS TAKEN ON (B)(6) 2012 WERE REPORTED AS NEGATIVE. A SURGICAL REVISION WAS THEN PERFORMED ON (B)(6) 20112 AT WHICH TIME IT WAS OBSERVED THAT THERE WAS MOISTURE IN THE CONNECTION BETWEEN THE EXTENSION AND THE LEAD. THE EXTENSION WAS THEN REPLACED. IT WAS NOTED THAT THE PATIENT HAD EXCELLENT RESULTS WITH NO ADVERSE "SITUATIONS" FOLLOWING THE EXTENSION REPLACEMENT AND THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    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 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention