BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 2002434 · Received January 28, 2011

    Report

    Report Number
    1627487-2011-00128
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 2, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) 2010. IT WAS REPORTED THAT HE IS WITHOUT STIMULATION AND UNABLE TO INCREASE THE AMPLITUDE FOR ANY OF HIS SET PROGRAMS. IN AN EFFORT TO RESOLVE THIS MATTER, A REPROGRAMMING APPOINTMENT WILL BE SCHEDULED. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3219 2926195

    Patients

    Seq Age Sex Outcome Treatment
    1