BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4161629 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01159
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL AND BENCH TESTING WITH NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS CONNECTED TO A HEART TRANSPLANTED PATIENT AT THE HOSPITAL. WHEN THE BATTERY WAS REPLACED, THE BACK UP PACING DID NOT WORK. AFTER THE BATTERY WAS REPLACED IT WOULD NOT START TO PACE, THE EPG HAD TO BE MANUALLY TURNED BACK ON. AS A RESULT OF THIS EVENT, THE PATIENT EXPERIENCED ASYSTOLE FOR 35 SECONDS DURING THE BATTERY EXCHANGE AND RESTART OF THE EPG. THE EPG WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND REPAIR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639982 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R