BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951425 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00009
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. EVALUATION SUMMARY (B)(4): THE EXTERNAL PULSE GENERATOR (EPG) WAS RETURNED AND ANALYZED, AND CONFIRMED THE CUSTOMER COMMENT THAT THE UPPER AND LOWER CASES WERE BROKEN AND CONTAMINATED. IT ALSO FOUND THAT THE VENTRICLE OUTPUT CONNECTOR WAS MISSING, THE BATTERY RELEASE, LEAD FLEX COVER, HEART BLOCK, RING COVER AND HEART WIRE CONTACTS WERE CONTAMINATED, TWO SIDE BAIL COVERS BROKEN, THE BATTERY CONTACTS COMPRESSED, THE RING BENT, THE BATTERY DRAWER BROKEN AND CONTAMINATED AND THE KEYBOARD PAD CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD BROKEN CONNECTORS AND "STANDOFFS," A MISSING VENTRICULAR INPUT, AND CRACKED UPPER AND LOWER CASES. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55655 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1