BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1252012 · Received December 4, 2008

    Report

    Report Number
    3004209178-2008-08008
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    September 16, 2008
    Report Date
    November 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT SURGICAL REPLACEMENT OF HIS LEADS. NO PT SYMPTOMS OR REASON FOR THE REPLACEMENT WERE NOTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention EXPLANTED| EXPLANTED| LEAD: MODEL 3999 LOT# V099867| EXTENSION: MODEL 37082 LOT# NKB013104N