BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2884752 · Received December 25, 2012

    Report

    Report Number
    3007566237-2012-03106
    Event Type
    Injury
    Date Received
    December 25, 2012
    Report Date
    July 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37651, SERIAL# UNKNOWN, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN POST-OP ISSUES IN COUPLING BETWEEN A RECHARGER AND AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD THE ACTIVA RC FOR A WHILE BUT IN THE LAST TWO WEEKS THE COUPLING WITH THE RECHARGER BECAME MORE DIFFICULT. WHEN USING ANOTHER RECHARGER, THE COUPLING BECAME BETTER, BUT WAS "STILL NOT GOOD ENOUGH." IT WAS THOUGHT THAT THE INS WAS IMPLANTED A BIT TOO DEEP BECAUSE THE PATIENT HAD GAINED SOME WEIGHT, BUT THERE WAS NO PROBLEM WITH CONNECTING TO THE PATIENT PROGRAMMER, N'VISION. PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. THE ACTIONS PLANNED AS A RESULT OF THE EVENT WERE INTRAOPERATIVE TESTING TO RULE OUT THAT THIS WAS AN INS PROBLEM AND TO PLACE THE INS CLOSER TO THE SURFACE, TOGETHER WITH HOSPITALIZATION. AFTER TWO AND A HALF WEEKS IT WAS ALSO REPORTED THAT THE SURGERY HAD GONE WELL. INTRAOPERATIVE TESTING WITH THE RECHARGER WAS DONE IN ORDER TO MAKE SURE THAT THE INS WAS CLOSE ENOUGH TO THE SURFACE. NOTHING WAS REPLACED, A NEW POCKET WAS MADE CLOSER TO THE SKIN. THE PATIENT WAS ABLE TO CHARGE THE INS NORMALLY AFTER THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention