BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX LEAD

    MDR report key: 4191795 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04671
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    August 1, 2012
    Manufacturer
    ST. JUDE MEDICAL INC. CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED TO THE EMERGENCY ROOM DUE TO INAPPROPRIATE SHOCKS. POOR SENSING AND PACING VALUES WERE OBSERVED ON BOTH LEADS. THE CAUSE WAS DETERMINED TO BE TWIDDLER SYNDROME. BOTH LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29570 ISOFLEX LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL INC. CRMD 1944/52

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention (B)(4)