BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88 LEAD KIT, 60 CM LENGTH

    MDR report key: 1980312 · Received February 2, 2011

    Report

    Report Number
    1627487-2011-00145
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2006. IT WAS REPORTED THAT HE LOST STIMULATION. AN INITIAL DIAGNOSTICS TEST REVEALED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS. FURTHER INTERROGATION WAS DONE VIA X-RAY; HOWEVER, NO VISIBLE ANOMALIES FOR THE LEAD WERE OBSERVED. FOLLOW-UP ON THIS MATTER FOUND THAT IMPEDANCE MEASUREMENTS FROM A SECOND DIAGNOSTIC TEST REVEALED INVALID READINGS FOR ONLY HALF OF THE PT'S LEAD CONTACTS. EFFECTIVE STIMULATION WAS RECAPTURED THROUGH REPROGRAMMING OF THE REMAINING VALID ELECTRODES. HOWEVER, THE PT HAS SINCE REPORTED FEELING AN OVERSTIMULATION SENSATION ACROSS HIS SACRAL REGION. THERE ARE NO IMMEDIATE PLANS FOR SURGICAL INTERVENTION AT THIS TIME DUE TO THE PT'S CURRENT HEALTH CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 LEAD KIT, 60 CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3288 40282

    Patients

    Seq Age Sex Outcome Treatment
    1