BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3488986 · Received November 26, 2013

    Report

    Report Number
    3004209178-2013-21439
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Report Date
    November 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V003289, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S BATTERY FAILED/DEPLETED AND THE CLINICIAN DECIDED IT WAS NOT WORTH THE TROUBLE TO DO A REPLACEMENT AT THIS POINT. THE CLINICIAN WOULD WAIT UNTIL THE OTHER INS DEPLETES. THE BATTERY FAILED WITHIN 2 YEARS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MANUFACTURER REPORT# 3004209178-2013-21436.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617609 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR