BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4460695 · Received January 28, 2015

    Report

    Report Number
    3004209178-2015-01356
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Report Date
    January 8, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# V971421, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V971421, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TOLD STIMULATION WOULD LAST FIVE YEARS, BUT ON THE DAY OF THE REPORT SHE CHECKED HER IMPLANTABLE NEUROSTIMULATOR (INS) AND SAW A PICTURE OF A DOCTOR AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) CODE. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS TOLD THE BATTERY WOULD LAST 5 YEARS AND IT ONLY LASTED 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64225 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR