BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952232 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00086
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S072
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DISPLAY WAS OUT OF SPECIFICATION, THE GASKET WAS PROTRUDED INTO THE SCREEN DISPLAY AREA CAUSING THE SCREEN TO BE HARD TO READ. IT WAS ALSO NOTED THAT THE UPPER CASE, LOWER CASE AND SIDE BAIL COVERS WERE BROKEN, THE BATTERY RELEASE, RING COVER, HEART BLOCK, BATTERY DRAWER AND BATTERY DRAWER O-RING WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE KEYBOARD WAS SCRATCHED, AND THE BATTERY FLEX WAS CORRODED. (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE MEMBRANE IN THE SCREEN DISPLAY AREA AND VENTRICULAR ADAPTER ARE BROKEN. IT WAS ALSO REPORTED THE SCREEN IS UNREADABLE. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MEMBRANE IN THE SCREEN DISPLAY AREA AND VENTRICULAR ADAPTER ARE BROKEN. IT WAS ALSO REPORTED THE SCREEN IS UNREADABLE. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55833 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1