BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1569994 · Received December 21, 2009

    Report

    Report Number
    3004209178-2009-09510
    Event Type
    Death
    Date Received
    December 21, 2009
    Date of Event
    November 26, 2009
    Report Date
    November 26, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE IMPLANTABLE PUMP WAS REPLACED IN 2009. THE DRUG DOSAGE OF THE NEW PUMP WAS 0.2 MG/DAY AT A CONCENTRATION OF 1 MG/ML. THE PT WAS STABLE AND DISCHARGED THE DAY AFTER IMPLANT. THE PT DIED THE FOLLOWING DAY. THE IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS EXPLANTED AT THE TIME OF PUMP REPLACEMENT (PLEASE SEE MFR. REPORT# 6000032-2009-09509). ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N223427003| ACCESSORY: MODEL 8590-1, LOT# N164184| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED:| EXPLANTED: