BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL CHAMBER PACEMAKER

    MDR report key: 7782 · Received February 4, 1994

    Report

    Report Number
    7782
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    August 25, 1993
    Report Date
    September 27, 1993
    Manufacturer
    CARDIAC PACEMAKERS, INC. CPI
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD FEVER, REDNESS, AND SWELLING AT THE SITE OF PACEMAKER WHICH HAD BEEN INITIALLY INSERTED 6/5/93. A CULTURE WAS TAKEN AND A STAPH AUREUS INFECTION WAS DIAGNOSED AT THE SITE. THE OLD PACEMAKER WAS REMOVED AND RETURNED TO THE MANUFACTURER ON AUGUST 25, 1993. A NEW PACEMAKER WAS INSERTED ON THE OPPOSITE SIDE WITHOUT FURTHER PROBLEM.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL CHAMBER PACEMAKER Implant PACEMAKER LWP CARDIAC PACEMAKERS, INC. CPI 940 TYPE DDD

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention