BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTH TRODE

    MDR report key: 67310 · Received February 7, 1997

    Report

    Report Number
    MW1010686
    Event Type
    Other
    Date Received
    February 7, 1997
    Date of Event
    January 22, 1997
    Report Date
    January 31, 1997
    Manufacturer
    CARDIOTRONICS, INC.
    Product Code
    LDD
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD CARDIOVERSION ON 1/22/97. SHORTLY AFTER PROCEDURE, RPTR NOTICED CHEST AND BACK ON LEFT SIDE HAD REDDENED RAISED AREA APPROX 10-15 CM IN DIAMETER WHERE STIMULATION ELECTRODE FOR CARDIOVERSION HAD BEEN APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTH TRODE STIMULATING ELECTRODE LDD CARDIOTRONICS, INC. * JULY 23 '98 210

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other