BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH ANCHOR

    MDR report key: 3141927 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-03710
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 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 2 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03709. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING STIMULATION IN HER PAIN PATTERN. X-RAYS CONFIRMED THE SCS LEAD HAD MIGRATED DUE TO THE SCS ANCHOR COMING LOOSE FROM THE PATIENT'S SPINOUS PROCESS. SUBSEQUENTLY, ON (B)(6) 2013 THE LEAD WAS REPOSITIONED BACK TO ITS ORIGINAL PLACEMENT AND THE SCS ANCHOR WAS SEWN DOWN. THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION POST OPERATIVELY. IT WAS REPORTED ON (B)(6) 2013 THE PATIENT'S SCS LEAD HAD MIGRATED AGAIN. SUBSEQUENTLY, THE PHYSICIAN REPOSITIONED THE LEAD AND ADDED AN ADDITIONAL MODEL 3186 LEAD. THE PATIENT RECEIVING EFFECTIVE STIMULATION POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233299 CINCH ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1194 3701495

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: