BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS XP 8-CHANNEL IPG

    MDR report key: 1940320 · Received December 17, 2010

    Report

    Report Number
    1627487-2010-03937
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT ((B)(6)) RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT DURING A LEAD RE-POSITIONING PROCEDURE, THE PHYSICIAN WAS UNABLE TO TIGHTEN THE IPG HEADER SCREWSET ONTO THE LEAD. THE IPG WAS REPLACED AT THAT TIME. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS XP 8-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW SJM NEUROMODULATION DIVISION 3609 116508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention