BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990552 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01037
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 CONFIRMED THE REPORTED EVENT, THE PRINTED CIRCUIT BOARD (PCB) HAD AN INTERMITTENT FAILURE. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. VISUAL INSPECTION REVEALED NO ANOMALIES. ALTHOUGH THE DEVICE FAILED ONE FUNCTIONAL TEST FOR SENSING, UPON RETESTING TEN TIMES, THE SAME FUNCTIONAL TEST PASSED. THE FAILURE WAS INTERMITTENT, SO THE COMPLAINT COULD NOT BE DEFINITIVELY CONFIRMED, BUT IT DOES SUGGEST AN ISSUE WITH TEST SETUP OR CALIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR (EPG) WAS ATTACHED TO A PATIENT THE EPG LOSS CAPTURE UNEXPECTEDLY. THE EPG WAS RETURNED TO THE MANUFACTURER FOR SERVICING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472056 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention