BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 2190926 · Received July 19, 2011

    Report

    Report Number
    1627487-2011-00976
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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

    DEVICE 2 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00975 AND 1627487-2011-00977. THE PT RECEIVED AN SCS SYS INCLUDING THREE PERCUTANEOUS LEADS ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S STIMULATION DOES NOT COVER HER AREA OF PAIN. EFFORTS TO RESOLVE THIS MATTER VIA REPROGRAMMING HAVE BEEN UNSUCCESSFUL THUS FAR. AN APPOINTMENT WITH THE PHYSICIAN HAS BEEN SCHEDULED FOR FURTHER EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 60 CM SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3116 3170780

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788| IMPLANTED:| SCS LEAD EXTENSION: MODEL 3342