BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3591850 · Received January 24, 2014

    Report

    Report Number
    3004209178-2014-01161
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Report Date
    January 3, 2014
    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

    PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40, LOT# V192123, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V902684, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT USED HER VIBRATOR BEFORE SHE GOT A "SHOCKING FEELING" BY HER INS (IMPLANTABLE NEUROSTIMULATOR). HER INS WAS IMPLANTED IN HER ABDOMEN. THIS HAPPENED THE OCCASIONAL TIME SHE USED THE VIBRATOR. IT WAS THAT SAME SIDE AS THE BEFORE (FOR INFORMATION ON THE PATIENT'S PREVIOUS INS ISSUE, SEE MANUFACTURER'S REPORT #3004209178-2014-01154). IT WAS LATER REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56836 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1