BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 2191567 · Received July 20, 2011

    Report

    Report Number
    1627487-2011-06008
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ADVANCED NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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

    THE PT RECEIVED AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT WAS WITHOUT STIMULATION AND UNABLE TO INCREASE THE AMPLITUDE FOR HIS THERAPY. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. AN X-RAY WAS ALSO TAKEN; HOWEVER, NO VISIBLE ANOMALIES WERE OBSERVED. THE PT IS WORKING CLOSELY WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 60 CM SPINAL CORD STIMULATION LEAD GZB ADVANCED NEUROMODULATION 3166 3218964

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention SCS IPG: MODEL 3716| IMPLANTED: