BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLETRA

    MDR report key: 1321717 · Received February 20, 2009

    Report

    Report Number
    6000032-2009-01191
    Event Type
    Death
    Date Received
    February 20, 2009
    Report Date
    January 24, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED NO ANOMALY FOUND; INS FUNCTIONALLY OK. FINAL DEVICE ANALYSIS OF THE EXTENSION REVEALED NO SIGNIFICANT ANOMALIES; EXTENSION OK, BUT CUT THRU (SUSPECT EXPLANT DAMAGE).

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATORS AND EXTENSIONS WERE RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO RETURN PAPERWORK. THE FUNERAL HOME WAS CONTACTED. THEY DID NOT HAVE ANY INFORMATION REGARDING THE EXACT CAUSE OF DEATH, BUT THEY DID NOT FEEL THE DEATH WAS DEVICE RELATED. SHE STATED THE CARE CENTER REMOVES THE DEVICES AT THE TIME OF THE PT'S DEATH IN PREPARATION FOR CREMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTHCARE PROFESSIONAL ON RECORD, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MANUFACTURER'S REPORT # 6000032-2009-01192 FOR PT'S OTHER DEVICE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO, MED REL 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LEAD: MODEL 3387| LOT# NFW122430H| EXTENSION: MODEL 7482| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED: