BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2813313 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01906
    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 CONFIRMED THE REPORTED EVENT, THE LOWER CASE AND ONE OUTPUT CONNECTOR WERE BROKEN AND ONE SIDE BAIL COVER WAS MISSING. IT WAS ALSO NOTED THAT THE UPPER CASE AND BATTERY DRAWER WERE BROKEN, THE BATTERY RELEASE AND RING COVER WERE CONTAMINATED, THE LEAD FLEX COVER WAS CORRODED, ONE CASE SCREW WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, ONE SIDE BAIL WAS MISSING, ONE RING BAIL WAS BENT, AND THE KEYBOARD WAS SCRATCHED.

    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 OUTPUT CONNECTOR, REAR CASE, AND BELT CLIP ARE BROKEN. THE DEVICE IS BEING RETURNED FOR REPAIR. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE OUTPUT CONNECTOR, REAR CASE, AND BELT CLIP ARE BROKEN. THE DEVICE IS BEING RETURNED FOR REPAIR. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE OUTPUT CONNECTOR, REAR CASE, AND BELT CLIP ARE BROKEN. 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