BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION, 30CM

    MDR report key: 2181467 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-00922
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REFERENCE MFR REPORT # 1627487-2011-00921. THESE TWO EXTENSIONS WERE INTENDED FOR PT IMPLANT IN THE NETHERLANDS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY CONNECTING BOTH DEVICES TO THE PT'S LEAD. PLACEMENT ATTEMPTS FOR THE FIRST EXTENSION WERE ABORTED. THE SECOND EXTENSION WAS EVENTUALLY CONNECTED; HOWEVER, INTRAOPERATIVE TESTING REVEALED INVALID IMPEDANCE MEASUREMENTS FOR TWO LEAD CONTACTS. IMPEDANCE READINGS REPORTEDLY IMPROVED SOMEWHAT WHEN THE PT'S LEAD WAS CONNECTED DIRECTLY TO THE IPG. THE CASE WAS COMPLETED WITH USE OF A THIRD EXTENSION. THAT DEVICE REMAINS IMPLANTED, AND EFFECTIVE STIMULATION WAS CAPTURED FOR THE PT VIA PROGRAMMING UTILIZING THE FUNCTIONING CONTACTS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, 30CM SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3254442

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention