BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152126 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01174
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    RICE CREEK MFG
    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

    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

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE DEVICE PASSED ALL INCOMING TESTS WITH NO ANOMALIES FOUND. IT IS NOTED THE CABLES RETURNED WITH THE DEVICE PASSED CONTINUITY AND VISUAL INSPECTION.

    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 AFTER THE PATIENT WAS IMPLANTED WITH A TEMPORARY WIRE AND CONNECTED TO THE EPG (EXTERNAL PULSE GENERATOR), THE EPG STARTED PACING. THE DOCTOR WANTED TO TEST EPG FUNCTION INCLUDING CAPTURE, THRESHOLD, AND SENSITIVITY. WHEN THE DOCTOR TESTED SENSITIVITY FUNCTION AND RATE TURNED TO 30 BPM (BEATS PER MINUTE), THE EPG DID NOT PACE. THE PACING RATE WAS INCREASED BUT THE EPG STILL DID NOT RESPOND. THE EPG WAS RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253323 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 5348D4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention