BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1922780 · Received November 12, 2010

    Report

    Report Number
    1627487-2010-03252
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 10, 2010
    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
    IN, 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

    IT WAS REPORTED ON (B)(6) 2010 THAT THE PT IS WITHOUT STIMULATION. REPROGRAMMING EFFORTS TO RECAPTURE STIMULATION WERE UNSUCCESSFUL. DIAGNOSTIC TESTS REVEALED HIGH IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS: HOWEVER, X-RAYS SHOWED NO VISIBLE ABNORMALITIES. PLANS FOR SURGICAL INTERVENTION ARE PENDING. THE IMPLANT DATE AS WELL AS THE LOT NUMBER FOR THE PT'S LEAD ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention