BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 2073675 · Received April 13, 2011

    Report

    Report Number
    1627487-2011-02435
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. THE PT REPORTED HER IPG HAS REACHED IT'S ESTIMATED REPLACEMENT TIME AND IS ONLY PROVIDING INTERMITTENT STIMULATION. AS ELECTROMAGNETIC INTERFERENCE IS SUSPECTED, THE PT IS WORKING CLOSELY WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3213646

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention