BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 428797 · Received November 13, 2002

    Report

    Report Number
    6000030-2002-00873
    Event Type
    Malfunction
    Date Received
    November 13, 2002
    Report Date
    October 25, 2002
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT STATED PUMP HAS BEEN ALARMING FOR MONTHS - SYMPTOMS OF ITCHING ALOT AND RETURN OF SPASTICITY. FOLLOW UP WITH HCP REVEALED THIS HCP HAD BEEN CALLED TO CARE FOR WHEN ADMITTED FOR PNEUMONIA. THE PUMP WAS INTERROGATED AT THAT TIME. THE BATTERY WAS FOUND TO BE DEAD AND THE PROGRAMMER COULD NOT COMMUNICATE WITH THE PUMP. HCP CONTACTED HOME HEALTH AGENCY REFILLING DEVICE AND FOUND THAT THE "LO" BATTERY ALARM HAD BEEN SOUNDING SINCE 03/2002. IT IS UNKNOWN IF THIS ISSUE HAS BEEN REPORTED TO AN APPROPRIATE HCP. PUMP WAS REPLACED. PATIENT HAS BEEN DOING WELL WTIH THE NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 861718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization CATHETER: MODEL 8703, LOT# J94142205, IMPLANT 1995| EXPLANT UNK.