BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4243581 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21323
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V297034, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V297034, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN END OF SERVICE (EOS) MESSAGE. THE PATIENT¿S BATTERY HAD DIED AND THEY WERE SCHEDULED FOR A BATTERY REPLACEMENT IN THREE WEEKS. THEY WERE ADMITTED TO THE HOSPITAL WITH A RETURN OF HIS TREMOR SYMPTOMS AND THEY WERE DEBILITATING. THE BATTERY HAD DIED AT THE END OF THE WEEK PRIOR TO REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED 10 DAYS LATER THAT THE PATIENT HAD A LOSS OF THERAPY AND THEIR TREMORS AND RIGIDITY HAD RETURNED. THE DEVICE HAD NOT BEEN EXPLANTED YET. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727508 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization