BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2201333 · Received August 3, 2011

    Report

    Report Number
    3004209178-2011-06017
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR HAD A LOW BATTERY. THE PT HAD TO RECHARGE HER DEVICE DAILY. A CHANGE IN THE PROGRESSION OF THE RECHARGING ISSUES WAS NOTED TO HAVE OCCURRED ABOUT ONE MONTH PRIOR TO REPORT. THE PT'S PROGRAMMING AND USAGE HAD NOT CHANGED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR PROGRAMMER: MODEL 37743, LOT# NKE135416N| LEAD: MODEL 39565-65, LOT# V336463012| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA020017N| IMPLANTED: