BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS PULSE GENERATOR, 8-CHANNEL

    MDR report key: 2040328 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-00342
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 WAS IMPLANTED WITH AN IPG ON (B)(6) 2004. IT WAS REPORTED THAT SHE HAS NOT UTILIZED THE STIMULATION IN OVER A YEAR DUE TO ALLEGATIONS THAT SHE NEVER RECEIVED EFFECTIVE THERAPY RELIEF. CURRENTLY, THE PATIENT IS UNABLE TO ESTABLISH COMMUNICATION WITH THE IPG USING TWO PROGRAMMERS. AN X-RAY HAS BEEN ORDERED FOR FURTHER INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS PULSE GENERATOR, 8-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3608 25617A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR