BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1031617 · Received April 16, 2008

    Report

    Report Number
    MW5006305
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 16, 2008
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PACEMAKER GENERATOR REPLACEMENT SURGERY, MEDTRONIC'S REPRESENTATIVE PROVIDED UNIQUE SERIAL NUMBER IDENTIFICATION FOR CORRECT LEAD IDENTIFICATION FROM MEDTRONIC CENTRAL DATABASE. PT WAS RECOVERED WITHOUT INCIDENT AND DISCHARGED LATER THAT DAY. PT RETURNED THE FOLLOWING DAY DUE TO COMPLAINTS OF SYNCOPE. PACER INTERROGATION IN THE ER INDICATED THAT THE LEAD CONNECTIONS WERE REVERSED. THE PT WAS PROMPTLY RETURNED TO THE OPERATING ROOM FOR CORRECTION OF LEAD CONNECTIONS. IN THIS CASE, TWO VENTRICULAR LEADS WERE USED IN THE ORIGINAL 1998 PROCEDURE DONE AT ANOTHER PRIVATE HOSPITAL. IT WAS DETERMINED THAT THE SERIAL NUMBERS FOR THE ATRIAL AND VENTRICULAR LEADS OF THIS PACEMAKER HAD BEEN REVERSED IN THE MEDTRONIC CENTRAL DATABASE AT THE TIME OF THE ORIGINAL INSERTION OF THE PACEMAKER IN 1998. THE PT TOLERATED THE PROCEDURE WELL. THE PACEMAKER WAS INTERROGATED PRIOR TO DISCHARGE IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PACKMAKER LWS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization