BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH ANCHOR

    MDR report key: 2181334 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-01779
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K081208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - THE ANCHOR WAS RETURNED DAMAGED IN TWO PIECES WITH THE METAL INSERTED IN ONE OF THE PIECES. THE SURFACE BETWEEN THE PROXIMAL AND DISTAL END INDICATES THAT THE ANCHOR WAS OVERSTRESSED. 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01781. THE PATIENT (B)(6) RECEIVED HIS SCS SYSTEM, INCLUDING A SURGICAL LEAD AND LEAD ANCHOR, ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT WENT CANOEING DESPITE THE PHYSICIAN'S INSTRUCTIONS TO AVOID THIS ACTIVITY. AFTER CANOEING, THE PATIENT REPORTED A LOSS OF STIMULATION AND RETURN OF HIS PAIN. DIAGNOSTIC TESTS REVEALED THAT STIMULATION COULD BE FELT WITH ONLY THREE LEAD CONTACTS. X-RAYS SHOWED THE LEAD WAS FRACTURED AND THE ANCHOR WAS DAMAGED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD AND ANCHOR ON (B)(6) 2011. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH ANCHOR SPINAL CORD STIMULATION LEAD ACCESSORY GZB ST. JUDE MEDICAL - NEUROMODULATION 1194 2764760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention