BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 3193555 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-10207
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-10208. IT WAS REPORTED THE PT (B)(6) STARTED TO FEEL UNCOMFORTABLE FOLLOWING AN EVENT WHERE SHE WAS CARRYING HEAVY WEIGHT AND STRETCHING. REPROGRAMMING DID NOT RESOLVE THE ISSUE. THE PHYSICIAN ELECTED TO PROCEED WITH SURGICAL INTERVENTION. INTRA-OPERATIVE TESTING IDENTIFIED THAT THE SCS LEAD AND LEAD EXTENSION WORKED PROPERLY. X-RAY IMAGERY REVEALED THE TIP OF THE LEAD EXTENSION HAD BECOME SEPARATED FROM THE IPG CONNECTOR. THE IPG WAS EXPLANTED AND REPLACED, WHICH RESOLVED THE REPORTED ISSUE. PLEASE NOTE: DEVICE INFORMATION FOR THE LEAD EXTENSION ASSOCIATED WITH THIS EVENT HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289039 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3529996

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other