BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR

    MDR report key: 2943338 · Received January 23, 2013

    Report

    Report Number
    1627487-2013-10021
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K092371
    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 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

    IT WAS REPORTED DURING THE PROCEDURE TO IMPLANT THE SCS SYSTEM, THE SCS LEAD ANCHOR BECAME DISENGAGED RESULTING IN LEAD MOVEMENT (UNITED KINGDOM). AFTER REPOSITIONING THE LEAD, THE LEAD ANCHOR WAS LOCKED AGAIN, THEN SUTURED IN PLACE USING THE PEEK GROOVES. THE PHYSICIAN REPORTED PART OF THE PEEK GROOVE SHEARED AWAY FROM THE LEAD ANCHOR. THE PHYSICIAN ELECTED TO LEAVE THE LEAD ANCHOR IN PLACE AS THE PROCEDURE HAD ALREADY TAKEN SOME CONSIDERABLE TIME AND SHE WAS WARY OF EXTENDING THE PROCEDURE FURTHER. THE ISSUE WITH THE LEAD ANCHOR ONLY EXTENDED THE PROCEDURE BY APPROXIMATELY TWO MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33800 ANCHOR SCS LEAD ANCHOR LGW ST. JUDE MEDICAL - NEUROMODULATION 1192 3517962

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention