BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1061484 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03253
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2007
    Report Date
    May 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0694-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS RESULTS REVEAL - BROKEN WELD(S) AT THE BOND WIRE PAD(S) - LIFTED BOND WIRE(S).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT'S HEALTH CARE PROVIDER (HCP) HAD BEEN UNABLE TO ADJUST THE PT'S DBS THERAPY FOR THE PAST YEAR. THE HCP WAS UNABLE TO READ OR RE-PROGRAM THE DEVICE WITH THE PROGRAMMER. THE DEVICE WAS NOT FLIPPED IN THE POCKET. THE PT HAD NO LOSS OF TREMOR CONTROL AND THE DEVICE SEEMED TO BE WORKING (PROVIDING THERAPY). SEVERAL TELEMETRY ATTEMPTS WERE MADE IN DIFFERENT LOCATIONS. THE DEVICE WAS FINALLY REPLACED IN 2008. THE PT WAS DOING WELL FOLLOWING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-66| LEAD: MODEL 3387| EXPLANTED: