BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1991996 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00897
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 20, 2011
    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

    RECEIVED INFO THE PT FELL ON (B)(6) 2010 AND LANDED ON HER BACK. SINCE THE FALL SHE HAS BEEN COMPLAINING OF SHOCKING/JOLTING SENSATION WITH STIMULATION TURNED ON. CURRENT IMPEDANCE MEASUREMENTS ARE NORMAL. ELECTRODES RANGE FROM 541-818 OHMS. GROUP A1: 493 OHMS AND A2: 628 OHMS. WITH STIMULATION TURNED ON, PT FEELS STIMULATION UP TO HER ARM AND SHOULDER AREA. IT SHOULD BE IN HER LOWER BACK AND LEG AREA. X-RAYS AND REPROGRAMMING WERE SUGGESTED BY MEDTRONIC PT SERVICES. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    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 EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD013277N| IMPLANTED:| STIM ACCCESSORY: MODEL 3550-29, LOT# N0027261| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA010705N| LEAD: MODEL 3777, LOT# N0030813| EXPLANTED: