BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2600099 · Received June 6, 2012

    Report

    Report Number
    3004209178-2012-04056
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Report Date
    May 8, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: NA, PRODUCT TYP EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: NA, PRODUCT TYP EXTENSION PRODUCT ID 7436, SERIAL# (B)(4), PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3387S-40, LOT# V161576, IMPLANTED: 2008-(B)(6), EXPLANTED: NA, PRODUCT TYP LEAD PRODUCT ID 3387S-40, LOT# V161576, IMPLANTED: 2008-(B)(6), EXPLANTED: NA, PRODUCT TYP LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE MEASURED ON THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOLLOWING AN INS REPLACEMENT SURGERY. THE PATIENT WAS NOT RECEIVING GOOD THERAPY ON THEIR RIGHT SIDE. THE DEVICE WAS PROGRAMMED WITH ELECTRODES 0 AND 3 ON THE LEFT AND 8 AND 11 ON THE RIGHT. IMPEDANCES BETWEEN 0 AND 3 WERE NORMAL, BUT IMPEDANCES BETWEEN ELECTRODES 8 AND 11 WERE >40000 OHMS. ADDITIONAL INFORMATION INDICATED THE ELECTRODES WERE CONFIGURED CORRECTLY DURING SURGERY (0-3 ON THE LEFT, 4-7 ON THE RIGHT) BUT THE RIGHT SIDE CONFIGURATION WAS INCORRECTLY CHANGED BY THE NEUROLOGIST IN THE CLINIC AT A LATER DATE (TO ELECTRODES 8 AND 11). THE ELECTRODES WERE RECONFIGURED TO THE SETTINGS USED DURING SURGERY, AND THE IMPEDANCES RETURNED TO NORMAL RANGES. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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 37601

    Patients

    Seq Age Sex Outcome Treatment
    1