BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2932142 · Received January 25, 2013

    Report

    Report Number
    1627487-2013-13113
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT COULD NOT BE CONFIRMED THROUGH PRODUCT TESTING ALONE. THE RETURNED LEAD WAS IN GOOD CONDITION, VISUAL INSPECTION NOTED NO ANOMALIES. THE DEVICE PASSED ALL FUNCTIONAL TESTING. NO OBSERVATIONS WERE MADE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. 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

    IT WAS REPORTED DURING A PROCEDURE, THE PT'S ELECTRICAL SIGNALS HAD DECREASED RAPIDLY AFTER A LEAD WAS IMPLANTED. THE PHYSICIAN OPTED TO REMOVE THE LEAD. THE PHYSICIAN FELT THERE WAS STENOSIS AND PERFORMED A LAMINECTOMY TO RELIEVE ANY PRESSURE. THE PT'S LEGS WERE MOVED; HOWEVER, THE SIGNAL DID NOT CHANGE. THE PHYSICIAN ABORTED THE CASE. IT WAS ALSO REPORTED THE PT HAD DECREASED MOTOR FUNCTION IN BOTH OF HIS LEGS POSTOPERATIVE. FOLLOW-UP INFORMATION IDENTIFIED THE PT WAS RE-IMPLANTED WITH ANOTHER LEAD AND ALSO IMPLANTED WITH AN IPG ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36261 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3855692

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention