BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860541 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00767
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE HEART RATE POTENTIOMETER WAS WORKING INTERMITTENTLY AND IT WAS ATTRIBUTED TO THE KNOB RATE BEING BROKEN. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES WERE DAMAGED, THE BATTERY RELEASE WAS CONTAMINATED, THE SIDE BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED AND THE KEYBOARD WAS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEART RATE POTENTIOMETER ON THE EXTERNAL PULSE GENERATOR WAS WORKING ONLY INTERMITTENTLY. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEART RATE POTENTIOMETER ON THE EXTERNAL PULSE GENERATOR WAS WORKING ONLY INTERMITTENTLY. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341653 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1