BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1936201 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03437
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: ONE OF THE LEADS HAD KINKS APPROX 29.5 CM AND 30.5 CM FROM THE TERMINAL END. BOTH LEADS PASSED CONTINUITY AND STRESS TESTING. 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 4. REFERENCE MFR REPORTS: 1627487-2010-03436, 1627487-2010-03438 AND 1627487-2010-03439. THE PT RECEIVED HIS SCS SYS, INCLUDING AN IPG, TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), AND TWO ANCHORS (FROM THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT REQUESTED HIS IPG BE EXPLANTED BECAUSE THE SYS WAS NOT HELPING HIS PAIN. MULTIPLE REPROGRAMMING SESSIONS WERE UNSUCCESSFUL IN RESOLVING THIS ISSUE. THE IPG WAS EXPLANTED ON (B)(6) 2010 AND RETURNED TO THE MFR FOR EVAL ON (B)(6) 2010. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 3093078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention