BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS PULSE GENERATOR, 8-CHANNEL

    MDR report key: 2051194 · Received April 6, 2011

    Report

    Report Number
    1627487-2011-00464
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 RECEIVED AN SCS SYSTEM INCLUDING A NON-RECHARGEABLE IPG ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT HAS OBSERVED THE LOW BATTERY WARNING FOR THE IPG. THE PATIENT'S PROGRAM PARAMETERS ARE NOT AVAILABLE FOR PURPOSES OF CONFIRMING WHETHER HIS IPG HAS REACHED ITS EXPECTED END-OF-LIFE. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO REPLACE THE DEVICE.

    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 83671

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention