BEUDAMED
    FDA Adverse Event Other Summary report: N

    CPI

    MDR report key: 157762 · Received March 10, 1998

    Report

    Report Number
    MW1013223
    Event Type
    Other
    Date Received
    March 10, 1998
    Date of Event
    March 2, 1998
    Report Date
    March 5, 1998
    Manufacturer
    CARDIAC PACEMAKER, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTED 2/11/98, ANTIBIOTIC PROPHYLAXIS GIVEN. PT DISCHARGED 2/12/98 FROM HOSP. PT SEEN IN ELECTRO PHYSIOLOGY STUDY CLINIC 2/13/98 AND 2/18/98 FOR WOUND CHECK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR CLINIC. ON 3/2/98 PT COMPLAINED OF REDNESS AT SITE. SHE WENT TO LOCAL ER, NO TEMPERATURE. GIVEN 2% BACTROBAN OINTMENT. ER MD GAVE DIAGNOSIS OF CELLULITIS PER PT. 3/4/98-SCHEDULED ELECTRO PHYSIOLOGY STUDY CLINIC APP'T ELECTRO PHYSIOLOGY STUDY DRS FEEL SITE IS NOT INFECTED OR CELLULITIS WOUND HAS HEALED WELL W/SOME ERYTHEMA IN LINEAR SHAPES, MOST LIKELY DUT TO TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPI Implant AICD LWS CARDIAC PACEMAKER, INC. 1762 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other 11. ZYFLO| 10. ZYRTREC| 8. VASOTEC| 1. LANOXIN| 12. DYTUSS| 6. NITRODUR| 7. CROMYLYN NA| 5. ZANTAC| 3. KCL| 2. LASIX| 13. ASTELIN| 9. ATROVENT| 4. GLYBURIDE