BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEMAKER

    MDR report key: 3658 · Received July 13, 1992

    Report

    Report Number
    3658
    Event Type
    Injury
    Date Received
    July 13, 1992
    Date of Event
    May 21, 1992
    Report Date
    June 4, 1992
    Manufacturer
    MEDTRONIC
    Product Code
    DRO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON MAY 21, 1992 A MEDTRONIC PACEMAKER SERIAL NUMBER 2T10028424 WAS EXPLANTED FROM A PATIENT AT OUR FACILITY BECAUSE THE PACEMAKER POCKET BECAME INFECTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant PACEMAKER DRO MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention