BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860015 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00809
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. FURTHER ANALYSIS WAS PERFORMED ON THE INTERCONNECT FLEX AND MAIN PCB. VISUAL INSPECTION REVEALED NO ANOMALIES. AFTER THE MAIN PCB AND INTERCONNECT FLEX WERE ASSEMBLED INTO AN ENGINEERING UNIT, A BENCH TEST WAS PERFORMED. THIS DID NOT REVEAL ANY ANOMALIES, THE DEVICE POWERED UP AND OPERATED TYPICALLY, LOCALIZED COOLING AND HEATING WAS APPLIED AS WELL AS FLEXING AND TAPPING, THE FAILURES SEEN DURING REPAIR OF THE DEVICE COULD NOT BE REPRODUCED. CONCLUSION: ALL SUBASSEMBLIES SUBMITTED FOR ANALYSIS PASSED TESTING.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE UPPER CASE WAS DAMAGED. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN, AND THE MAIN PRINTED CIRCUIT BOARD (PCB) AND INTERCONNECT FLEX WERE OUT OF ELECTRICAL SPECIFICATION.

    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 OUTPUT CONTROL HAS A ROUGH SPOT AROUND 5 MILLAMP WHEN IT IS TURNED. IT WAS ALSO REPORTED THE DEVICE MAY HAVE BEEN DROPPED. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341798 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1