BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4161691 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02653
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT. LONG TERM TESTING REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EXTERNAL PULSE GENERATOR (EPG) WAS BEING USED ON A PATIENT, THE RATE CHANGED WITHOUT ANY USER INTERACTION. INITIALLY, THE RATE ON THE EPG WAS SET TO 100 BPM, THEN IT JUMPED TO 80 BPM WITHOUT ANY USER INTERACTION. THE USER THEN UNLOCKED THE DEVICE AND SET THE RATE BACK TO 100 BPM, THE RATE THEN JUMPED TO 60 BPM, AGAIN WITHOUT USER INTERACTION. THE USER DISCONTINUED THE USE OF THE DEVICE AT THIS POINT. CALLER STATED THE BATTERY WAS REPLACED TEN DAYS PRIOR TO THE INCIDENT. IT WAS RECOMMENDED BY TECHNICAL SERVICES TO RETURN THE DEVICE FOR REPAIR. THE DEVICE WAS LATER RETURNED TO THE MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EXTERNAL PULSE GENERATOR (EPG) WAS BEING USED ON A PATIENT, THE RATE CHANGED WITHOUT ANY USER INTERACTION. INITIALLY, THE RATE ON THE EPG WAS SET TO 100 BPM, THEN IT JUMPED TO 80 BPM WITHOUT ANY USER INTERACTION. THE USER THEN UNLOCKED THE DEVICE AND SET THE RATE BACK TO 100 BPM, THE RATE THEN JUMPED TO 60 BPM, AGAIN WITHOUT USER INTERACTION. THE USER DISCONTINUED THE USE OF THE DEVICE AT THIS POINT. CALLER STATED THE BATTERY WAS REPLACED TEN DAYS PRIOR TO THE INCIDENT. IT WAS RECOMMENDED BY TECHNICAL SERVICES TO RETURN THE DEVICE FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640065 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention