BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1059470 · Received June 10, 2008

    Report

    Report Number
    3004209178-2008-03124
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    August 1, 2006
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE MEDTRONIC KINENTRA/SOLETRA LIFTED BOND WIRE RECALL (2007). LIFTED BOND WIRE COULD NOT BE CONFIRMED IN THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED AMBULATION DIFFICULTIES, RETURN OF TREMOR, AND HAD DIFFICULTIES COMPLETING ACTIVITIES OF DAILY LIVING. AN X-RAY WAS PERFORMED (2006), NO FRACTURES WERE DETECTED IN THE DEEP BRAIN STIMULATION SYSTEM. THERE WAS ALSO NO RESPONSE FROM THE LEFT NEUROSTIMULATOR (INS) WHEN TELEMETRY WAS ATTEMPTED. THE PT'S LEFT INS AND EXTENSION WERE REPLACED. THE PT REGAINED THERAPEUTIC BENEFIT. THE PT RECOVERED WITHOUT SEQUELA.

    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 70 YR Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387| EXPLANTED:| EXTENSION: MODEL 7482