BEUDAMED
    FDA Adverse Event Other Summary report: N

    PATIENT PROGRAMMER

    MDR report key: 925231 · Received October 9, 2007

    Report

    Report Number
    2182207-2007-03316
    Event Type
    Other
    Date Received
    October 9, 2007
    Date of Event
    September 1, 2007
    Report Date
    September 11, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT USED HIS SPINAL CORD STIMULATOR FOR AN INDEFINITE PERIOD LENGTH OF TIME, SO THE BATTERY WAS OVER DISCHARGED. THE MANUFACTURER'S REPRESENTATIVE INSTRUCTED THE PATIENT ON HOW TO PERFORM THE PHYSICIAN MODE RECHARGE IN ORDER TO "JUMP START" THE BATTERY. THE PATIENT "PUSHED THE GREEN BUTTON" TWICE AND WAS ABLE TO GET THE BATTERY CHARGED UP TO 25%. THE PATIENT THEN RECHARGED HIS BATTERY NORMALLY UNTIL IT WAS FULLY CHARGED. THE PATIENT WAS LATER SEEN IN HIS PHYSICIAN'S OFFICE FOR REPROGRAMMING. NO PATIENT SYMPTOMS OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT PROGRAMMER LGW MEDTRONIC NEUROMODULATION 37742 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT# NJB001355N| IMPLANTED| EXPLANTED| LEAD MODEL 3777 LOT# N0034891