BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211123 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06143
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 13, 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
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERIODIC "ZAPPING" SENSATION WHILE RECHARGING. THE PATIENT'S ANTENNA HAD BEEN STEPPED ON, BUT OTHERWISE APPEARED TO BE WORKING AS INTENDED. IT WAS SUGGESTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR SOMETIMES FLIPPED ON ITS SIDE, THOUGH THIS HAD NOT BEEN CONFIRMED AS OF THE DATE OF THIS REPORT. THE PATIENT WAS TO CONTACT THE PHYSICIAN AND/OR THE MANUFACTURER REPRESENTATIVE FOR FOLLOW-UP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 38 YR RECHARGER: MODEL 37752, LOT# NKA144466N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V522460019| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154212N| STIM ACCESSORY: MODEL 37092, LOT# 253500001