BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2160612 · Received July 6, 2011

    Report

    Report Number
    1627487-2011-03210
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    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: AS RECEIVED, THE LEAD SHOWED A FRACTURE AND BROKEN WIRES OF THE DISTAL END OF THE ANCHOR PLACEMENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BROKEN WIRES. 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

    THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAD LOST STIMULATION AND INVALID IMPEDANCES WERE OBSERVED ON MULTIPLE CONTACTS. THE LEAD WAS REPLACED AND THE STIMULATION WAS CAPTURED POSTOPERATIVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3175257

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192