BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT LOW IMPEDANCE LEAD

    MDR report key: 1022586 · Received April 1, 2008

    Report

    Report Number
    6000153-2008-01702
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THERE HAD BEEN A LOSS OF THERAPEUTIC EFFECT; SHE HAD EXPERIENCED SYMPTOMS OF NUMBNESS IN HER LEFT LEG AND WHEN STIMULATION WAS TURNED DOWN, THERE WAS NO STIMULATION DETECTED IN HER ARM (AFFECTED SIDE WAS NOT PROVIDED). THERE HAD BEEN NO ACCIDENT OR TRAUMA AND THE PATIENT STATUS HAD BEEN DEEMED FAIR. SHE ANTICIPATED SURGICAL REVISION IN TWO DAYS BECAUSE THE LEFT LEAD HAD MIGRATED. THE FIELD STAFF HAD CONTACTED THE PATIENT; STIMULATION LEVELS HAD BEEN DEEMED TOO HIGH BY THE REPRESENTATIVE (NO VALUES WERE REPORTED). THE PATIENT HAD BEEN ADVISED TO LOWER THE STIMULATION LEVELS PRIOR TO REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT LOW IMPEDANCE LEAD LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 3778 V052591033

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| LOT # NKL702823H| IMPLANTABLE NEURO STIMULATOR MODEL 37702| EXPLANTED| EXTENSION MODEL 37081