BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 1071937 · Received July 10, 2008

    Report

    Report Number
    6000094-2008-00336
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 21, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: NO ANOMALIES WERE FOUND. PROXIMAL SEGMENT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A SCHEDULED FOLLOW-UP, UNSTABLE/HIGH PACING IMPEDANCES AND OVERSENSING WAS OBSERVED. THE LEAD TO DEVICE CONNECTION WAS CHECKED, WITH PACING IMPEDANCE AGAIN BECOMING STABLE. TEN DAYS LATER, THE IMPEDANCE AGAIN BECAME UNSTABLE, AND MANIPULATION OF THE DEVICE IN THE POCKET SHOWED NOISE ON THE EGM. BOTH THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING LEAD FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT STATUS WAS REPORTED TO BE GOOD FOLLOWING THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention