BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1812453 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06144
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 15, 2010
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PT REPORTED SHE WAS UNABLE TO RECHARGE HER IPG DUE TO HEALTH REASONS AND THINKS IT MAY BE OVERDISCHARGED BECAUSE NOW IT WON'T RECHARGE. IPG WAS REPLACED. 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 ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention LEAD: MODEL 3777, LOT # V048439004| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3772, LOT # NJD043797N| LEAD: MODEL 3777, LOT V028023011| ACCESSORY: MODEL 37752, LOT # NKA031865N