BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGOR DDD PULSE GENERATOR

    MDR report key: 94074 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-00907
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    December 17, 1996
    Report Date
    December 12, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PATIENT WITH THIS IMPLANTABLE PULSE GENERATOR (IPG), MODEL 950, AND BIPOLAR LEAD, MODEL 4285, EXPERIENCED AN EPISODE OF ASYSTOLE AND HAD TO BE EXTERNALLY RESCUED WHILE IN THE RECOVERY ROOM FOLLOWING THE IMPLANT PROCEDURE. ECG STRIPS SHOWED A PROGRESSION FROM LOSS OF CAPTURE TO NO OUTPUT. INTERROGATION OF THE IPG IN THE OR SHOWED APPROPRIATE PARAMETERS AND MEASURED DATA. AT THIS TIME THE PATIENT WAS BEING PACED EXTERNALLY. THE PATIENT WAS TAKEN BACK TO THE OR. THE WOUND WAS RE-OPENED AND LEAD POSITIONING WAS RECHECKED. THE PHYSICIAN ELECTED TO IMPLANT A NEW IPG, MODEL 955, AND BIPOLAR LEAD, MODEL 4269, ALONG WITH A CHRONIC MEDTRONIC LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGOR DDD PULSE GENERATOR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS 0950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention THE DEVICE 4285/215950 WAS IMPLANTED