BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMINGTON

    MDR report key: 1210963 · Received October 23, 2008

    Report

    Report Number
    MW5008750
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 23, 2008
    Manufacturer
    REMINGTON MEDICAL, INC
    Product Code
    DSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTRICULAR PACEMAKER CABLE BENT AT BLACK CONNECTION, CABLE FRACTURED, PT WAS ASYSTOLIC X 2. CPR WAS PERFORMED. PHYSICIAN AT BEDSIDE, CABLE REPLACED. PT STABILIZED. DIAGNOSIS OR REASON FOR USE: EXTERNAL PACING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMINGTON DISPOSABLE SURGICAL CABLE DSA REMINGTON MEDICAL, INC S-101-97 081971

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening