BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 88C SURGICAL LEAD

    MDR report key: 1934561 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03322
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 RECEIVED HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT WAS NOT FEELING STIMULATION. THE PROGRAMMER SHOWED THAT THE AMPLITUDE REMAINED AT THE PERCEPTION LEVEL FOR ALL PROGRAMS AND COULD NOT BE INCREASED. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AS IMPEDANCES WERE INVALID FOR ALL LEAD CONTACTS. AN X-RAY WILL BE SCHEDULED TO HELP DETERMINE THE CAUSE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88C SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3289 2798901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention