BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2813356 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01907
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE 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.

    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 FOUND THAT THE VENTRICULAR OUTPUT CONNECTOR LOCKING MECHANISM WAS OCCLUDED BY FOREIGN MATERIAL, THE LOWER CASE WAS BROKEN AND CONTAMINATED, THE UPPER CASE WAS BROKEN AND DENTED, THE BATTERY RELEASE WAS CONTAMINATED, BOTH BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS SCRATCHED, THE DISPLAY WAS BLEEDING PIXELS, AND THE BATTERY DRAWER O-RING WAS MISSING.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISPLAY IS MISSING DIGITS AND "BAD" AND THE REAR CASE IS DAMAGED. THE DEVICE IS BEING RETURNED FOR REPAIR. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISPLAY IS MISSING DIGITS AND "BAD" AND THE REAR CASE IS DAMAGED. THE DEVICE IS BEING RETURNED FOR REPAIR. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISPLAY IS MISSING DIGITS AND "BAD" AND THE REAR CASE IS DAMAGED. THE DEVICE IS BEING RETURNED FOR REPAIR. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other