BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC PULSE GENERATOR

    MDR report key: 7744 · Received February 4, 1994

    Report

    Report Number
    7744
    Event Type
    Malfunction
    Date Received
    February 4, 1994
    Date of Event
    April 23, 1993
    Report Date
    July 30, 1993
    Manufacturer
    SIEMENS PACESETTER INC.
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NON FUNCTIONAL "TEMPORARY OFF" DURING PROGRAMING. LEAD OVERSENSING IN VENTRICLE. REPLACED.DEVICE LABELED FOR SINGLE USE. 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. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, MODIFICATION OF DEVICE, RATE-MODULATED PACING SENSING FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant CARDIAC PULSE GENERATOR JOQ SIEMENS PACESETTER INC. 2020T

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other