BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 1981736 · Received January 20, 2011

    Report

    Report Number
    1981736
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A LEAD REVISION AND THE SET-SCREW WAS REMOVED TEMPORARILY TO REPOSITION THE LEAD. WHEN THE SCREW WAS REINSERTED, IT WOULD NOT ANCHOR PROPERLY. IT APPEARED AS THOUGH THE THREADS HAD BEEN STRIPPED. THE PROPER #2 HEX WRENCH WAS SUPPLIED BY THE CLINICAL SPECIALIST FROM MEDTRONIC THAT WAS PRESENT FOR THE PROCEDURE. ANOTHER PACEMAKER WAS IMPLANTED. THE PATIENT'S OUTCOME WAS POSITIVE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================POSSIBLE STRIPPED THREADS====================== MANUFACTURER RESPONSE FOR MEDTRONIC SENSIA SR PACEMAKER WITH SET SCREW, MEDTRONIC SENSIA SR PACEMAKER (WITH SET SCREW INCLUDED)======================NO RESPONSE FROM MFG .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. SESR01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR