BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991160 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02180
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE VENTRICULAR OUTPUT CONNECTOR WAS OCCLUDED BY A BROKEN PIN. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER AND BOTH BAIL COVERS WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE RING AND BOTH BAILS WERE MISSING, AND THE KEYBOARD WAS OUT OF SPECIFICATION, THE LOCK AND PAUSE BUTTONS WERE "SQUISHY".

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BROKEN PIN WAS STUCK INSIDE THE VENTRICULAR PORT OUTPUT CONNECTOR. THE EXTERNAL PULSE GENERATOR (EPG) HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472123 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1