BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSAFE ENDOCARDIAL PACING LEAD

    MDR report key: 116677 · Received August 29, 1997

    Report

    Report Number
    2522457-1997-00016
    Event Type
    Injury
    Date Received
    August 29, 1997
    Date of Event
    July 14, 1997
    Report Date
    August 15, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 7/28/94, A 67 YEAR OLD FEMALE PATIENT UNDERWENT A NORMAL BATTERY DEPLETION PACEMAKER REPLACEMENT. A NEW PULSE GENERATOR WAS IMPLANTED TO THE EXISTING LEAD. ON 1/15/97, PATIENT DEVELOPED AN INFECTION AT THE POCKET/PACEMAKER SITE. PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER AND ANOTHER PULSE GENERATOR WAS IMPLANTED TO THE EXISTING LEAD. ON 8/15/97, THE MFR RECEIVED A REPORT THAT THE ABOVE REF. PATIENT DEVELOPED ANOTHER INFECTION WITH A SECOND REPLACEMENT PACEMAKER. IT WAS REPORTED THE EXISTING LEAD HAD ERODED UNDER THE PATIENTS ARM (SIDE OF CHEST). ON 7/14/97, PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER SYSTEM AND REPLACED IT WITH ANOTHER MFR'S PACEMAKER 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-333 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization