BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3107666 · Received May 10, 2013

    Report

    Report Number
    3004209178-2013-07526
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40 LOT# V143392, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40 LOT# V143392, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF ON ITS OWN THE SUMMER PRIOR TO REPORT. IT WAS ALSO REPORTED, THE PATIENT'S HEALTHCARE PROVIDER GOT HIM "SQUARED AWAY AGAIN" AND TESTED THE DEVICE AND STATED "EVERYTHING WAS FINE." REFERENCE REGULATORY REPORT #3004209178-2013-07524.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208782 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1