BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3992244 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02403
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 THE BIOMEDICAL ENGINEER (BE) STATED THAT THE LOWER DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG) DID NOT COME ON. IT WAS ALSO NOTED THAT THE RATE AND OUTPUT COULD NOT BE ADJUSTED. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE IN RESOLVING THE ISSUE BY HAVING THE BE CHECK THE BATTERY AND THE BE INDICATED IT WAS A NEW BATTERY WHICH MEASURED 7.1 VOLTS. THE BATTERY WAS SUBSEQUENTLY REPLACED AND THE EPG OPERATED AS DESIGNED. THE EPG WAS RESTORED AND PLACED BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471791 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1