BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4163415 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01244
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    July 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
    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 DETERMINED THAT THE UPPER AND LOWER CASES WERE BROKEN AND THAT THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF SPECIFICATION ELECTRICALLY AND THAT IT NEEDED INTERCONNECT WASHERS. (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 MAIN PRINTED CIRCUIT BOARD (PCB). VISUAL INSPECTION REVEALED NO ANOMALIES. BENCH ANALYSIS CONFIRMED THE CURRENT DRAIN FUNCTIONAL TEST ISSUE. HOWEVER ANALYSIS WAS HALTED DUE TO COMPLEXITY OF POSSIBLE CAUSE. CONCLUSION: CONFIRMED THE ACTIVE CURRENT DRAIN FAILURE, BUT COULD NOT SUCCESSFULLY ISOLATE THE FAULT DUE TO FAILURE COMPLEXITY.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED AS A TRADE-IN/EXCHANGE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639827 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1