BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2171028 · Received June 30, 2011

    Report

    Report Number
    3004209178-2011-04968
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    January 1, 2010
    Report Date
    June 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    THE PATIENT EXPERIENCED COUPLING AND COMMUNICATION ISSUES WHEN TRYING TO RECHARGE HER IMPLANTABLE NEUROSTIMULATOR (INS). HER INS WAS IN A POWER ON RESET CONDITION. THE PATIENT HAD GAINED WEIGHT AND HAD DIFFICULTY RECHARGING HER INS. THE INS EXPERIENCED A THIRD OVERDISCHARGE AND COULD NO LONGER BE RECHARGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR EXPLANTED:| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTED: