BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3102358 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07422
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN: PRODUCT ID 3389S-40, LOT# V535392, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V535392, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) AND THAT NIGHT THE STIMULATOR JUST TURNED OFF. THE PATIENT HAD LOST HIS PROGRAMMER AND WAS NOT ABLE TO TURN THE STIMULATION BACK ON. A REPLACEMENT PROGRAMMER WAS ORDERED FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203862 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR