BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3461756 · Received November 12, 2013

    Report

    Report Number
    3004209178-2013-20530
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Report Date
    October 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64002, LOT# N230038, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3387S-40, LOT# V011138, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0555643V, IMPLANTED: (B)(6)2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN PATIENT RECEIVED AN ELECTIVE REPLACEMENT INDICATOR (ERI). IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY IS AT 2.5 5VOLTS. PATIENT SAW ERI MESSAGE LATE LAST SPRING. PATIENT WAS TOLD INS WOULD LAST 5-7 YEARS. STIMULATOR HAD BEEN IMPLANTED JUST OVER A YEAR PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585843 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Female "SEE H10...."