BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2220255 · Received August 16, 2011

    Report

    Report Number
    1627487-2011-01845
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: VISUAL ANALYSIS OF THE LEAD NOTED A SEVERE KINK WITH ALL WIRES BROKEN. SOME REDDISH DISCOLORATION WAS OBSERVED WITHIN THE INNER TUBING. DUE TO THE WIRE DAMAGE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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

    THE PT (B)(6) RECEIVED AN SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT HAD A SUDDEN LOSS OF STIMULATION THAT OCCURRED WHEN THE PT SAT DOWN. X-RAYS SHOWED THE LEAD HAD FRACTURED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD ON (B)(6) 2011. EFFECTIVE STIMULATION WAS REPORTED POSTOPERATIVE. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD, 60 CM LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3244501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention