BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITRELL GENERATOR

    MDR report key: 5023 · Received June 17, 1993

    Report

    Report Number
    5023
    Event Type
    Injury
    Date Received
    June 17, 1993
    Date of Event
    May 10, 1993
    Manufacturer
    MEDTRONIC
    Product Code
    DSZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PACEMAKER REMOVED DUE TO LOW BATTERY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITRELL GENERATOR Implant PACEMAKER DSZ MEDTRONIC 7420 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention