BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE LEAD 3/4MM, 30 CM

    MDR report key: 2181456 · Received July 5, 2011

    Report

    Report Number
    1627487-2011-00908
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00909. THE PT RECEIVED AN SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS ON (B)(6) 2008. IT WAS REPORTED THAT THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. A DIAGNOSTIC TEST REVEALED HIGH IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT VIA REPROGRAMMING UTILIZING THE FUNCTIONING CONTACTS. THERE ARE NO PLANS FOR FURTHER INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD 3/4MM, 30 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3143 R86977

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANTED:| LEAD EXTENSION: MODEL 3346| IMPLANTED:| IMPLANTED:| LEAD EXTENSION: MODEL 3386| SCS IPG: MODEL 3716