BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991789 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00968
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED CAPTURING ISSUE; THE ISSUE WAS CONFIRMED VIA FUNCTIONAL TESTING. ANALYSIS CONFIRMED THE REPORTED ISSUE OF THE UPPER /LOWER CASES BROKEN AND BATTERY DRAWER BROKEN. ANALYSIS ALSO FOUND THE RING IS BENT.

    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 COULD NOT CONFIRM THE REPORTED CAPTURING ISSUE; THERE WAS A TIMEOUT OF THE DEVICE DURING FUNCTIONAL TESTING; CAUSE UNKNOWN. ANALYSIS CONFIRMED THE REPORTED ISSUE OF THE UPPER /LOWER CASES BROKEN AND BATTERY DRAWER BROKEN. ANALYSIS ALSO FOUND THE RING IS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE IS NOT CAPTURING. IT WAS ALSO REPORTED THE CASES AND BATTERY HOLDER HAVE CRACKS. THE DEVICE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472433 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1