BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC PACEMAKERS, INC.,

    MDR report key: 216134 · Received June 2, 1997

    Report

    Report Number
    216134
    Event Type
    Injury
    Date Received
    June 2, 1997
    Date of Event
    March 7, 1997
    Report Date
    May 19, 1997
    Manufacturer
    CARDIAC PACEMAKERS INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT TRANSFERRED TO THIS INSTITUTION WITH A HISTORY OF AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILATOR GENERATOR CHANGE 2/25/1997. ON 3/5/1997 COMPLAINTS OF THREE EPISODES OF SEVERE SHOCKS WITH ONE HALF AN HOUR WITH MINIMAL ACTIVITY AND AMBULATION. THE SENSING LEAD WAS FOUND TO BE PICKING UP OUTSIDE ACTIVITY. IT WAS ALSO FOUND THAT SEVERAL SENSES WERE FOUND TO HAVE BEEN ABORTED PRIOR TO THE DELIVERY OF THE SHOCK. ON RADIOLOGICAL EXAMINATION 3 TINY LINEAR DEFECTS WERE NOTED AT THE LEVEL OF THE THORAX, DID NOT INVOLVE THE ENTIRE DIAMETER OF THE LEAD. A NEW LEAD WAS PLACED WITH DIFFICULTY ENCOUNTERED IN POSITIONING OF THE NEW LEAD. THERE WAS "MPT" ENOUGH TRABECULATION TO ENGAGE THE LEAD. THE OLD LEAD HAD BEEN PLACED UP SOMEWHAT ONTO THE SEPTUM BECAUSE A SIMILAR PROBLEM HAD BEEN NOTED AT THE ORIGIANL IMPLANTATION. PT RECOVERED WELL AND WAS DISCHARGED TO HOME 3/7/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PACEMAKERS, INC., Implant PACEMAKER LEAD DTB CARDIAC PACEMAKERS INC. BT10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention