BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2430267 · Received January 27, 2012

    Report

    Report Number
    3004209178-2012-00588
    Event Type
    Injury
    Date Received
    January 27, 2012
    Report Date
    January 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 3389S-40 LOT# V041062 IMPLANTED: (B)(6) 2007 EXPLANTED: NA; EXTENSION MODEL 7482A51 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA; PROGRAMMER MODEL 37642 SERIAL# (B)(4); NEUROSTIMULATOR MODEL 37602 SERIAL# (B)(4) IMPLANTED: (B)(6) 2011 EXPLANTED: NA; LEAD MODEL 3389S-40 LOT# V063950 IMPLANTED: (B)(6) 2007 EXPLANTED: NA; EXTENSION MODEL 7482A51 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FROM THEIR IMPLANTABLE NEUROSTIMULATOR AND HAD A TREMOR ON THEIR RIGHT SIDE. THE PATIENT FELT STIMULATION AROUND HER JAW AND NECK AREA, ON HER RIGHT SIDE AS WELL. A REVISION OF THE INS WAS PERFORMED AND THE PHYSICIAN DECIDED TO LOOSEN UP THE EXTENSION IN THE SCAR TISSUE, TO HELP ALLEVIATE TENSION. THE LEAD EXTENSION CONNECTION WAS RELOCATED TO THE NECK REGION, INSTEAD OF OUTSIDE THE SKULL. X-RAYS DETERMINED THAT VERY CLOSE TO THE LEAD EXTENSION CONNECTION, THE WIRES WERE UNCOILED/STRETCHED. IMPEDANCES WERE NORMAL BUT IT WAS NOTED THAT A LEAD/EXTENSION REVISION WILL BE SCHEDULED WITHIN THE NEXT MONTH. ADDITIONAL INFORMATION HAD 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 MDT PUERTO RICO OPERATIONS CO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention