BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 3830786 · Received May 23, 2014

    Report

    Report Number
    2017865-2014-05646
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    January 17, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE INSULATION WAS ABRADED AT 4.7 CM TO 4.8 CM FROM THE CONNECTOR PIN, EXPOSING THE OUTER COIL, DUE TO FRICTION WITH THE DEVICE CAN. THE INSULATION WAS ALSO ABRADED AT 3.2 CM TO 3.5 CM AND 30.5 CM TO 31.3 CM FROM THE DISTAL TIP, EXPOSING THE OUTER COIL, DUE TO FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED LOW LEAD IMPEDANCE. THE LEAD REMAINED IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THE LEAD EXHIBITED NOISE AND DURING POST EXTRACTION THERE APPEARS TO BE AN INSULATION ANOMALY. THE LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307337 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 1488T/52

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention