BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1885189 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08411
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    January 1, 2007
    Report Date
    June 11, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS OF IMPLANTABLE PULSE GENERATOR (IPG) REVEALED NO ANOMALY FOUND - IPG IS FUNCTIONALLY OK. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE WAS REPLACED AFTER DEVICE STOPPED WORKING FOLLOWING AN MRI. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB000702N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# V007342| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB002016N