BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 3071803 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06716
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. HIGH OUTPUTS BETWEEN OCT 2012 AND FEB 2013 WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 THAT THE PATIENT'S DEVICE INDICATED HIGH THRESHOLD THROUGH CAPTURE MANAGEMENT. WHEN THE DEVICE WAS MANUALLY TESTED, THE THRESHOLDS WERE WITHIN NORMAL RANGE. WHEN A SECOND IN-OFFICE CAPTURE MANAGEMENT TEST WAS DONE, THE DEVICE ABORTED THE TEST DUE TO HIGH THRESHOLD. THE CAPTURE MANAGEMENT WAS TURNED TO "MONITOR ONLY" AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172219 VERSA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention 5076 X2 IMPLANTABLE PACING LEADS