BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60CM

    MDR report key: 2023352 · Received March 16, 2011

    Report

    Report Number
    1627487-2011-00354
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    DEVICE 2 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00353 AND 1627487-2011-00355. THE PATIENT RECEIVED AN SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG AND TWO SURGICAL LEADS. HE HAS SINCE UNDERGONE SURGICAL PROCEDURES TO REPLACE THE ORIGINAL IPG AND ONE OF THE ORIGINAL LEADS (REFERENCE MFR REPORT #S 1627487-2009-00095 AND 1627487-2010-00218). IT WAS REPORTED THAT THE PATIENT'S CURRENT IPG AND LEADS WERE EXPLANTED DUE TO A FALL HE RECENTLY SUFFERED. THE INCIDENT ALLEGEDLY RESULTED IN THE LOSS OF STIMULATION FOR THE PATIENT AND PAIN ON HIS RIGHT SIDE. A REPLACEMENT SYSTEM WILL BE IMPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 60CM SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3166 3062357

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention