BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 2930517 · Received January 24, 2013

    Report

    Report Number
    1627487-2013-05135
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    February 1, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 3 OF 3. REFERENCE MFR. REPORT#: 1627487-2014-05133, 05134. THE PATIENT HAD TWO LEADS (FROM THE SAME LOT) AND TWO ANCHORS (FROM THE SAME LOT). IT WAS REPORTED THE PATIENT HAD LOST STIMULATION. AROUND THE TIME THE PATIENT LOST STIMULATION, SHE STOPPED RECHARGING THE IPG. ON (B)(6) 2013, THE PATIENT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE, THE ANCHORS WERE FOUND TO BE FRACTURED AND THE LEADS WERE DAMAGED. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED AND REPLACED. STIMULATION WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33974 ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1194 (X2) 3117707

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention