BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1913545 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09411
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT HAD BEEN EXPERIENCING A SUDDEN SHOCKING SENSATION FROM THEIR STIMULATION DEVICE OVER THE PAST YEAR. IT WAS NOTED THAT 2 MOBILE PHONES, 2 NOTEBOOKS, AND HIS TV WENT BLANK AFTER THESE SHOCKS OCCURRED. PROGRAMMING ADJUSTMENTS WERE CONDUCTED BY REDUCING THE VOLTAGE AND INCREASING THE RATE. TESTING WAS DONE BY CALLING THE PT ON HIS MOBILE PHONE. THE PT FELT SHOCKS EVERY TIME HIS PHONE WOULD RING. THE SHOCKING EXPERIENCE WOULD DIFFER IN RANGE FROM MILD, MODERATE, TO SEVERE EVEN THOUGH THE SAME SETTING OF VOLTAGE AND RATE WAS APPLIED. THE PT WAS TRAINED ON HOW TO ADJUST THEIR VOLTAGE AND RATE SETTING. THE PT WAS TO FOLLOW UP WITH THEIR PHYSICIAN IN A TIMEFRAME OF ONE MONTH. THE PT'S OUTCOME WAS NOT REPORTED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1