BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1222364 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07216
    Event Type
    Death
    Date Received
    November 5, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE REPORT FROM THE CORONER INDICATED THAT THE PATIENT EXPIRED APPROXIMATELY 1 DAY AFTER THE PUMP WAS REFILLED. THE PUMP CONTAINED FENTANYL AND CLONIDINE; CONCENTRATION AND DOSES NOT REPORTED. THE CAUSE OF DEATH OR IF IT WAS DEVICE RELATED WERE UNKNOWN AT THE TIME OF THIS REPORT. THE INVESTIGATION WAS ON-GOING; TOXICOLOGY REPORTS WERE PENDING AT THE TIME OF THE REPORT. IT IS UNK IF THE DEVICE WOULD BE RETURNED TO THE MFR FOR ANALYSIS. THE CORONER WAS INQUIRING ABOUT INDEPENDENT PUMP ANALYSIS. THE PATIENT HAD AN IMPLANTED RESTORE SCS SYSTEM AS WELL AS THE INTRATHECAL DRUG PUMP SYSTEM. THE PATIENT WAS REPORTEDLY ON OTHER ORAL PAIN MEDICATIONS, INCLUDING VICODIN, AS WELL. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. PLEASE SEE MFR. REPORT # 2182207200807187.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LEAD MODEL 3777 LOT# V002103 IMPLANTED| LOT# NGV006600N IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD019510N IMPLANTED| IMPLANTABLE PUMP SYSTEM MODEL 863740| EXPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3777 LOT# J0564195V IMPLANTED