BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 3992157 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14902
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 30, 2014
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2010.

    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 DEVICE WAS PROGRAMMED DOO AT MAX OUTPUTS DUE TO RIGHT VENTRICULAR (RV) LEAD OVERSENSING WITH PAUSES. THE DEVICE THEN TRIPPED THE ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS ALSO REPORTED THAT THE LEAD IMPEDANCE WAS 3,000 OHMS. BECAUSE THE PATIENT IS DEPENDENT, THE DEVICE WAS PROGRAMMED FOR EMERGENCY PACING AND THE PATIENT HAD POCKET STIMULATION WITH UNIPOLAR. THE DEVICE WAS THEN PROGRAMMED TO MAX OUTPUT AND THE RV LEAD SENSITIVITY WAS PROGRAMMED TO 11.2 MV. THE DEVICE AND LEAD WERE REMOVED AND REPLACED TWO DAYS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470632 VERSA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Hospitalization| R 5076-45 LEAD