BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2143075 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-03135
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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

    SJM HAS LIMITED INFO 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

    (B)(6) THE PT REC'D AN SCS SYS, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION IN HIS LEGS. DIAGNOSTIC TESTS REVEALED LOW IMPEDANCE READINGS FOR THESE LEAD CONTACTS. AN X-RAY INDICATED NO ANOMALIES. THE PHYSICIAN EXPLANTED THE LEAD ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS WERE OBSERVED.

    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 3088700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL 3688| IMPLANT: