BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2040333 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-01240
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR ALLEGED EVENTS HAVE OCCASIONALLY RESULTED IN THE EXPLANT OF THE LEAD. SJM HAS LIMITED INFORMATION 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-01239. THE PT REC'D HIS SCS SYSTEM, INCLUDING AN IPG AND PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION. THE PT STATED THAT THE AMPLITUDE DOES NOT ADVANCE PAST PERCEPTION LEVEL. HE WILL BE SCHEDULED FOR A REPROGRAMMING SESSION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3163 2790276

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention