BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSAFE ENDOCARDIAL PACING LEAD

    MDR report key: 121407 · Received September 16, 1997

    Report

    Report Number
    2522457-1997-00014
    Event Type
    Injury
    Date Received
    September 16, 1997
    Date of Event
    August 13, 1997
    Report Date
    August 14, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH A SINGLE-LEAD ATRIAL SYNCHRONOUS VENTRICULAR PACEMAKER SYSTEM. THE MFR RECEIVED A REPORT THAT THE PT FELL AND INTERRUPTED NORMAL OPERATION OF PACEMAKER AND IT WAS BELIEVED THE LEAD BECAME DISLODGED. UPON INTERROGATION OF THE PACEMAKER SYSTEM, PHYSICIAN ACCIDENTLY CUT THE LEAD AND HAD TO REPLACE IT WITH ANOTHER. PACEMAKER WOULD NOT PACE IN THE VDD MODE WITH THE NEW LEAD ONLY IN VVI. PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER AND LEAD AND REPLACED IT WITH ANOTHER PULSE GENERATOR AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSAFE ENDOCARDIAL PACING LEAD Implant PACING LEAD DTB CARDIAC CONTROL SYSTEMS, INC AT-443 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization