BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860659 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00759
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION.

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) AND INTERCONNECT FLEX WERE OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB AND THE INTERCONNECT FLEX. VISUAL INSPECTION NOTED A METALLIC THREAD, HOWEVER RESISTANCE MEASUREMENT DID NOT INDICATE A SHORT. NO VISUAL ANOMALIES WERE NOTED ON THE INTERCONNECT FLEX, TAIL THICKNESS WAS WITHIN SPECIFICATION. NO ANOMALIES WERE NOTED WITH EITHER SUBASSEMBLY DURING BENCH OR FUNCTIONAL TESTING. CONCLUSION: ALL SUBASSEMBLIES SUBMITTED FOR ANALYSIS PASSED TESTING.

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE FUNCTION WAS NOT RESPONDING ON THE EXTERNAL PULSE GENERATOR (EPG) DURING A MAINTENANCE CHECK. IT HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339369 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1