BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3992361 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02398
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EXTERNAL PULSE GENERATOR (EPG) WAS POWERED ON, THE DISPLAY CAME ON, BUT THE RATE OR OUTPUT COULD NOT BE ADJUSTED. THE BATTERY VOLTAGE COULD NOT BE MEASURED. THE CALLER INDICATED WHEN ASKED, THAT THE BATTERY IS REPLACED "APPROXIMATELY EVERY THREE MONTHS." TECHNICAL SERVICES (TS) EXPLAINED TO THE CALLER THAT THE BATTERY IS TO BE REPLACED WITH EVERY NEW PATIENT. TS PROVIDED ASSISTANCE IN RESOLVING THE ISSUE BY HAVING THE CALLER REPLACE THE BATTERY AND THE EPG THEN OPERATED AS DESIGNED. THE EPG WAS RESTORED TO USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467516 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1