BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860432 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01482
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE BATTERY CONTACTS WERE COMPRESSED AND THE RING WAS BENT. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR TESTING AND CALIBRATION. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340219 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1