BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991622 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00982
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 20, 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 DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: INITIAL ANALYSIS FOUND THAT THE MAIN PRINTED CIRCUIT BOARD (PCB) AND INTERCONNECT FLEX HAD INTERMITTENT FAILURES. FURTHER ANALYSIS WAS PERFORMED ON THESE PARTS. VISUAL INSPECTION REVEALED NO ANOMALIES. BENCH AND FUNCTIONAL ANALYSIS ALSO REVEALED NO ANOMALIES. CONCLUSION: NO DEFECT FOUND, COULD NOT CONFIRM THE FAILURES SEEN DURING REPAIR OF THE DEVICE.

    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. (B)(4).

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR CALIBRATION, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470878 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1