BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS

    MDR report key: 3122323 · Received April 12, 2013

    Report

    Report Number
    1627487-2013-10117
    Event Type
    Other
    Date Received
    April 12, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES: 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 RELATED TO THIS EVENT 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-10118, REFERENCE MFR REPORT: 1627487-2013-10119. IT WAS REPORTED THE EXPIRATION DATES PRINTED ON THE LABELS FOR 3 IPGS WERE DIFFERENT THAN THE EXPIRATION DATES DOCUMENTED ON THE DELIVERY VOUCHER. ALL THREE DEVICES ARE FROM THE SAME LOT. THERE WAS NO PT INVOLVEMENT ASSOCIATED WITH THIS ISSUE (FRANCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158854 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3951250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA