BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2113703 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03936
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MDT 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). THE IMPLANTABLE NEUROSTIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED COUPLING AND COMMUNICATION ISSUES AND HAD DIFFICULTY RECHARGING HER IMPLANTABLE NEUROSTIMULATOR (INS). THE INS STOPPED WORKING AND SHE WAS UNABLE TO ACTIVATE IT. THE PATIENT HAD A REVISION SURGERY AND THE INS WAS EXPLANTED AND REPLACED. SHE WAS NOT INJURED AND RECOVERED WITHOUT SEQUELA. THE PATIENT WAS DOING VERY WELL AFTER THE REVISION AND WAS RECEIVING EFFECTIVE STIMULATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANTED:| STIM ACCESSORY: MODEL 3550-P4, LOT# N240310| LEAD: MODEL 39565-65, LOT# V398369046| ACCESSORY: MODEL 37752, LOT# NKA140183N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE147930N| EXPLANTED:| EXPLANTED: