BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152125 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00522
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE UNIT SHUT ITSELF OFF. ANALYSIS DID FIND A RING BAIL BENT. THE GENERATOR WAS RECALIBRATED AND FUNCTIONALLY TESTED AND PASSED ITS FINAL QUALITY ASSURANCE (QA) TESTS. (B)(4).

    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).

    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 THE PHYSICIAN INSERTED A TEMPORARY PACING LEAD IN THE RIGHT VENTRICLE AND CONNECTED TO THE EPG (EXTERNAL PULSE GENERATOR) AND MADE SURE THE EPG HAD WORKED. WHEN THE PATIENT WENT BACK TO ICU (INTENSIVE CARE UNIT), IT WAS FOUND THAT THE EPG HAD SUDDENLY TURNED OFF. THE NURSE CHANGED TO ANOTHER EPG AT THAT TIME TO MAKE THE PATIENT SITUATION STABLE. THE EPG WAS RETURNED FOR EXAMINATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN INSERTED A TEMPORARY PACING LEAD IN THE RIGHT VENTRICLE AND CONNECTED TO THE EPG (EXTERNAL PULSE GENERATOR) AND MADE SURE THE EPG HAD WORKED. WHEN THE PATIENT WENT BACK TO ICU (INTENSIVE CARE UNIT), IT WAS FOUND THAT THE EPG HAD SUDDENLY TURNED OFF. THE NURSE CHANGED TO ANOTHER EPG AT THAT TIME TO MAKE THE PATIENT SITUATION STABLE. THE EPG WAS RETURNED FOR EXAMINATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252454 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention