BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4143082 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-03627
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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 2. REFERENCE MFR REPORT: 1627487-2014-03623. THE PATIENT HAS 2 SCS LEADS. IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS EVENT; THEREFORE, BOTH ARE BEING REPORTED. IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCED LOSS OF RIGHT LEG STIMULATION. DIAGNOSTICS SHOWED INVALID IMPEDANCE VALUES FOR THE SCS LEAD RELATED TO THIS EVENT. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED WHICH RESOLVED THE REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591288 UNKNOWN SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other