BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD KIT, 90CM LENGTH

    MDR report key: 2010778 · Received March 2, 2011

    Report

    Report Number
    1627487-2011-00272
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 15, 2011
    Report Date
    February 1, 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
    NV, US
    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 WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. EFFORTS TO RECAPTURE EFFECTIVE THERAPY VIA REPROGRAMMING PROVED UNSUCCESSFUL. AN X-RAY REVEALED THAT THE LEAD HAD FRACTURED AND WAS MIGRATING OUT OF THE EPIDURAL SPACE. IN ADDITION, ONE OF THE CONTACTS WAS NO LONGER ATTACHED TO THE DEVICE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011, TO REPLACE THE PATIENT'S LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-8 LEAD KIT, 90CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3268 2861787

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention