BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZY PACING LEAD

    MDR report key: 177331 · Received July 13, 1998

    Report

    Report Number
    1035166-1998-00029
    Event Type
    Death
    Date Received
    July 13, 1998
    Date of Event
    November 12, 1995
    Report Date
    April 6, 1998
    Manufacturer
    SULZER OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT HE WAS RETAINED TO REPRESENT INTERESTS FOR CLAIMS ARISING OUT OF A WRONGFUL DEATH. THE REPORTER CLAIMS THAT THE PT'S DEATH WAS A DIRECT AND PROXIMATE RESULT OF RECEIVING A DEFECTIVE AND CONTAMINATED PACEMAKER. THE PT WAS IMPLANTED WITH AN ELA MEDICAL PACEMAKER MODEL T84F AND AN OSCOR ENDOCARDIAL BIPOLAR/IN-LINE ATRIAL J LEAD ON 10/12/1995. THE PACEMAKER WAS EXPLANTED ON 10/24/1995 AND THE PT DIED ON 11/12/1995, ALLEGEDLY DUE TO COMPLICATIONS ARISING FROM AN INFECTION. THE REPORTER STATED THAT A REVIEW OF THE MEDICAL RECORDS AND DISCUSSIONS WITH THE RELEVANT TREATING DOCTORS IN THIS CASE INDICATES THE PACEMAKER WAS CONTAIMINED DURING THE MFG AND PACKAGING PROCESS. THE REPORTER ALSO STATED THAT DESPITE BEING ADMITTED TO THE ICU AND IMPLEMENTATION OF AGGRESSIVE ANTIBIOTIC THERAPY, THE PT SUCCUMBED TO THE STAPHYLOCOCCUS AUREUS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZY PACING LEAD Implant PACEMAKER LEAD DTB SULZER OSCOR INC. ZY52PJBV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death ELA MEDICAL PACEMAKER MODEL T84F.