BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952058 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00074
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. IT WAS NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE HIGH RATE COVER WAS OUT OF SPECIFICATION, THE MAIN KEYPAD WAS COSMETICALLY DAMAGED, THE BATTERY FLEX WAS OUT OF SPECIFICATION, AND THE HEART LEAD FLEX WAS CONTAMINATED. (B)(4).

    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

    APPROXIMATELY 6 WEEKS AGO, A FIELD CORRECTIVE ACTION WAS INITIATED FOR THE SUSPECT MEDICAL DEVICE NOTED IN SECTION D WHICH MAY INVOLVE INTERMITTENT PERFORMANCE OF CERTAIN PACING FUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BEATS PER MINUTE (BPM) ON THE EXTERNAL PULSE GENERATOR (EPG) DID NOT MATCH THE COUNT ON THE TESTER. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BEATS PER MINUTE (BPM) ON THE EXTERNAL PULSE GENERATOR (EPG) DID NOT MATCH THE COUNT ON THE TESTER. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57767 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1