BEUDAMED
    FDA Adverse Event Summary report: N

    PACEMAKER

    MDR report key: 7079 · Received October 26, 1993

    Report

    Report Number
    7079
    Date Received
    October 26, 1993
    Manufacturer
    TELECTRONICS PACING SYSTEMS, INC.
    Product Code
    DXY
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS RETURNED TO HOSP C/O DR BY THE WRITTEN REQUEST OF THE FAMILY. INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACEMAKER DXY TELECTRONICS PACING SYSTEMS, INC. META

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data