BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD, 60CM LENGTH

    MDR report key: 2080395 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-00533
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    THE PATIENT ((B)(6)) WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2007. IT WAS REPORTED THAT SHE SUFFERED A FALL IN (B)(6) 2009. SINCE THAT TIME, SHE HAS UNDERGONE REPROGRAMMING TO REGAIN EFFECTIVE STIMULATION; HOWEVER, HER THERAPY RELIEF PROGRESSIVELY DIMINISHED AND EVENTUALLY CEASED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PATIENT'S LEAD, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-8 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3286 2841195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention