BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951486 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00012
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES WERE BROKEN AS WAS ONE SIDE BAIL COVER, THAT THE RING COVER WAS CONTAMINATED AND THAT THE RING BAIL WAS BENT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INSPECTION OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER DISCOVERED THAT THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INSPECTION OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER DISCOVERED THAT THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57154 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1