BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3062957 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06426
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 29, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V054604, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V054604, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37651, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE INS WAS TOO DEEP BUT NOT FLIPPED. ON (B)(6) 2013 THE PATIENT UNDERWENT A POCKET REVISION. FOLLOWING THE REVISION THE NEUROLOGIST CONFIRMED THAT THE PATIENT PROGRAMMER WAS WORKING AND THE RECHARGER RECEIVED EIGHT COUPLING BARS DURING RECHARGE SESSIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT GET ANY COUPLING BETWEEN THE RECHARGER UNIT AND THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT DID NOT SEE ANY COUPLING BARS ON THE RECHARGER SCREEN. THE PATIENT WAS RECENTLY IMPLANTED AND WAS A LITTLE SORE (BUT NOT SWOLLEN) WITH A THIN BANDAGE OVER THE SITE. THE INS WAS REPORTED TO BE 75% CHARGED. USING THE ANTENNA LOCATOR (AL) FEATURE, THE PATIENT WAS ABLE TO GET 38 BARS THEN 48 BARS WHEN THE RECHARGER WAS REPOSITIONED. HOWEVER, THE PATIENT WAS STILL UNABLE TO ACHIEVE ANY COUPLING. FURTHER INFORMATION OBTAINED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT THAT AFTERNOON AND WAS UNABLE TO GET ANY COUPLING WHEN RECHARGING THE DEVICE. IT WAS OBSERVED THAT INS WAS IMPLANTED TOO DEEP OR THAT THE DEVICE WAS POSSIBLY FLIPPED. IT ALSO REPORTED THAT NO COUPLING COULD BE ACHIEVED BETWEEN THE PROGRAMMER AND THE INS ALTHOUGH IT WAS CONFIRMED THAT THE DEVICE EQUIPMENT WAS WORKING FINE. IT WAS ALSO NOTED THAT THE PATIENT WAS VERY OBESE, AND TOGETHER WITH THE INS POSITION ISSUE, WOULD HAVE COUPLING/RECHARGING ISSUES GOING FORWARD. THE REPRESENTATIVE WAS GOING TO DISCUSS THE ISSUE WITH THE PATIENT'S PHYSICIAN AND RECOMMEND A REVISION OF THE INS POCKET. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166030 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention