BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2103706 · Received May 24, 2011

    Report

    Report Number
    1627487-2011-00707
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS CORRECTED AND THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS RETURNED, THE WIRES IN THE LEAD WERE BROKEN. THE COMPRESSION MARKS ON THE LEAD FROM THE SWIFT LOCK WHEN ALIGNED TO THE SWIFT LOCK PLACEMENT SHOWED THE FRACTURE WAS AT THE DISTAL END OF THE ANCHOR. NO FUNCTIONAL TESTING COULD BE PERFORMED ON THE LEAD DUE TO THE RECEIVED CONDITION OF THE DEVICE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 INCLUDING TWO PERCUTANEOUS LEADS ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION AND UNABLE TO INCREASE THE AMPLITUDE FOR HIS THERAPY. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS FOR ONE OF THE LEADS. AN X-RAY WAS ALSO TAKEN; HOWEVER, NO VISIBLE ANOMALIES WERE OBSERVED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE IMPACTED DEVICE, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3153759

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANT:| IMPLANT:| SCS IPG: MODEL 3788| SCS LEAD ANCHOR: MODEL 1192