BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 239112 · Received September 3, 1999

    Report

    Report Number
    6000030-1999-00158
    Event Type
    Malfunction
    Date Received
    September 3, 1999
    Date of Event
    April 6, 1999
    Report Date
    April 22, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT TELEPHONED MFR TO INQUIRY REGARDING EXPECTED LIFE OF DEVICE. DEVICE HAD LASTED 30 MONTHS BEFORE EXPLANT. PT HAD POSSESSION OF EXPLANTED DEVICE AND RETURNED IT TO MFR FOR ANALYSIS. MFR RECORDS INDICATE THAT DEVICE WAS SHIPPED TO HOSP 09/25/1995, IMPLANTED 1996. DEVICE HAD A LABELED "USE BEFORE DATE" OF 1996. DEVICE ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8615LS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization CATHETER MODEL 8700A IMPLANTED 1992.