BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS PULSE GENERATOR, 8-CHANNEL

    MDR report key: 2051334 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-00463
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT ((B)(6)) WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT COMMUNICATION WITH THE DEVICE WAS DIFFICULT AND A LOW BATTERY WARNING HAD BEEN OBSERVED. THE WARNING MESSAGE WAS CLEARED ON THE PT'S PROGRAMMER, BUT TELEMETRY WAS LOST WHEN ATTEMPTING TO RE-ESTABLISH COMMUNICATION BETWEEN THE IPG AND THE PROGRAMMER. THE PT'S IPG WAS REPLACED AND NO FURTHER COMPLICATIONS WERE REPORTED.

    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 2934531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention