BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2153375 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03156
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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: THE RETURNED LEAD REVEALED COMPRESSION WITH ALL WIRES BROKEN. THE COMPRESSION MARKS ON THE LEAD FROM THE CINCH ANCHOR WHEN ALIGNED TO THE ANCHOR SHOWED THE FRACTURE AND BROKEN WIRES WERE AT THE DISTAL (MALE) END OF THE ANCHOR. NO FUNCTIONAL TESTING COULD BE PERFORMED ON THE FRACTURED LEAD DUE TO BROKEN WIRES. 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 RECEIVED AN SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT HAD LOST STIMULATION AND COULD NO LONGER TURN THE STIMULATION UP TO ANY PERCEPTION LEVEL. ALL CONTACTS EXHIBITED INVALID IMPEDANCES AND A LEAD FRACTURE WAS OBSERVED. NO FURTHER INFO 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 2807559

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1194 (2)