BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLETRA

    MDR report key: 1210306 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06792
    Event Type
    Death
    Date Received
    October 22, 2008
    Date of Event
    May 21, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS RESULTS WERE NOT AVAILABLE ON THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED, WHEN DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT'S DBS SYSTEM WAS RETURNED TO THE MFR WITH NO INFO. THE MFR'S DEVICE TRACKING SYSTEM INDICATED THE PT EXPIRED IN 2008. THE CAUSE OF DEATH IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    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 Death PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| EXTENSION MODEL 7482 LOT#NHU039024V| EXPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL 3387 LOT# J0401877V| EXPLANTED| EXPLANTED| STIM ACCESSORY MODEL BURRHOLE CAP LOT# UNK| IMPLANTED| LOT#NFW116039H| IMPLANTED| EXTENSION MODEL 7482 LOT#NHU039023V| IMPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL 3387S LOT# V006339| IMPLANTED| STIM ACCESSORY MODEL BURRHOLE RING LOT# UNK| IMPLANTED