BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2080515 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-01416
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    February 9, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: TWO EXTENSIONS WERE RETURNED. VISUAL ANALYSIS NOTED DISCOLORATION IN THE STRAIN RELIEF, IN THE LEAD SEGMENT AND AT THE TERMINAL END ELECTRODE FOR BOTH EXTENSIONS. EXTENSION B HAD BROKEN WIRES AT THE CONNECTION BETWEEN THE STRAIN RELIEF AND THE LEAD SEGMENT. EXTENSION A FAILED THE CONTINUITY TEST (CHANNELS 5 THROUGH 8 MEASURED INVALID). EXTENSION B FAILED THE CONTINUITY AND RESISTIVITY TESTS (CHANNELS 2, 5 THROUGH 8 MEASURED INVALID). 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 6 OF 6. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01207, 1627487-2011-01221, 1627487-2011-01406, 1627487-2011-01414 AND 1627487-2011-01415. IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANT/REPLACEMENT PROCEDURE FOR HIS LEADS AND EXTENSIONS. DURING THE SURGERY, THE PHYSICIAN NOTICED THAT THERE WAS BLOOD/FLUID IN THE HEADER OF THE PATIENT'S IPG. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE IPG DURING THE PROCEDURE ON (B)(6) 2011. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3383 25117

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention