BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS CONVENTIONAL IPG

    MDR report key: 2043132 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01162
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT RECEIVED A LOW BATTERY FLAG ON (B)(6) 2011. THE PT REPORTED THAT HE STILL HAD STIMULATION. BASED ON THE PT'S IPG SETTINGS, IT WAS CALCULATED THAT THE PT IPG SHOULD LAST APPROX 31 MONTHS. FOLLOW UP ON THE PT FOUND THAT THE MESSAGE HAD BEEN CLEARED, AND THE LOW BATTERY FLAG WAS MOST LIKELY RELATED TO PASSIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3608 2809942

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention