BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2113747 · Received June 2, 2011

    Report

    Report Number
    3004209178-2011-03920
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 8, 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, LEAD, AND EXTENSION HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT'S IMPLANTABLE NEUROSTIMULATOR (INS), LEAD, AND EXTENSION WERE EXPLANTED AND REPLACED. THE LEAD HAD FRACTURED. THE INS WAS FUNCTIONING NORMALLY BUT THE PT AND HEALTH CARE PROFESSIONAL DECIDED TO REPLACE IT BECAUSE IT WAS ABOUT (B)(6). THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL ANCHOR, LOT# UNKNOWN| STIM ACCESSORY: MODEL ANCHOR, LOT# UNKNOWN| EXTENSION: MODEL 37082, LOT# NKB000764N| IMPLANTED:| LEAD: MODEL 3998, LOT# V266015| IMPLANTED:| IMPLANTED: