BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44 LEAD, 110CM LENGTH

    MDR report key: 2182357 · Received July 11, 2011

    Report

    Report Number
    1627487-2011-00951
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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 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 TWO SURGICAL LEADS FOR BILATERAL UPPER EXTREMITY TO TOP OF THE SHOULDER PAIN ON (B)(6) 2010. IT WAS REPORTED THAT FOLLOWING A COUGHING SPELL THE PT EXPERIENCED SIGNIFICANT OVERSTIMULATION. ADDITIONALLY, HER STIMULATION COVERAGE IS REPORTEDLY INADEQUATE. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ONE OF HER LEAD CONTACTS. EFFORTS TO RECAPTURE EFFECTIVE THERAPY COVERAGE VIA REPROGRAMMING PROVED UNSUCCESSFUL. THE PT IS WORKING CLOSELY WITH HER NEUROSURGEON TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 LEAD, 110CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3263 2867094

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788