BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2952811 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00714
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    February 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE LEAD'S HELIX WAS DISTORTED (EXTRINSIC) FROM PULLED/STRETCHED/OVERSTRESSED AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYSIS COMMENTS STATED THAT THE LEAD WAS RETURNED WITH HELIX STRETCHED; THEREFORE THE HELIX EXTENSION/RETRACTION/LENGTH TESTING COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE WHILE PLACING THE SCREW-IN LEAD INTO THE ATRIUM, SUDDENLY IT WAS FOUND THE LEAD HAD STUCK UNDER THE APPENDAGE. IT HAD BEEN CLEARLY SEEN UNDER THE C-ARM (AFTER MAGNIFYING) THE SCREW OF THE LEAD WAS OPENED AND ANCHORED INSIDE THE MUSCLE ALTHOUGH THE LEAD HAD NEVER BEEN SCREWED THROUGHOUT THE PROCESS. AFTER SEVERAL ATTEMPTS DOCTOR WAS ABLE TO WITHDRAW THE LEAD FROM IT. AFTER EXTRACTION IT IS CLEARLY SHOWN THE SCREW OF THE LEAD IS WIDE OPEN. A NEW LEAD WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55798 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICQ09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR