BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1220434 · Received November 4, 2008

    Report

    Report Number
    3004209178-2008-07159
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 7, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/07/2008, THE EXTENSION HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SHOCKING IN THE RIGHT BODY WHICH WENT AWAY WHEN THE LEFT DEEP BRAIN STIMULATION SYSTEM WAS TURNED OFF. HIGH IMPEDANCES WERE NOTED ON THE LEFT STIMULATOR SYSTEM. THE HCP DECIDED TO REPLACE THE LEFT EXTENSION. AT REPLACEMENT SURGERY, IT WAS DETERMINED THAT THERE WAS A BREAK IN THE LEFT LEAD. THE HCP REPLACED THE EXTENSION AND SENT IT TO THE MANUFACTURER FOR ANALYSIS. LEAD REPLACEMENT SURGERY WAS SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 62 YR Required Intervention EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387S| LOT #NFW140016H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| EXTENSION: MODEL 7482| PROGRAMMER: MODEL 7438| EXTENSION: MODEL 7482| EXPLANTED:| LEAD: MODEL 3387S| EXPLANTED: