BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3860032 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10652
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 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
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT MEDICAL PRODUCTS: 5076-45, LEAD, (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    SAVE TO DISK CLINICAL DATA REVIEW WAS DETERMINED TO BE NOT REQUIRED BECAUSE PHYSICAL ANALYSIS WAS COMPLETED.

    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 WAS FEELING POCKET STIMULATION FROM THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS REPROGRAMMED SO THAT THE PATIENT WOULD NOT FEEL THE PACING OUTPUT. THE IPG WAS LATER REMOVED AND REPLACED FOR ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS ALSO REPORTED THAT LEAD WARNINGS TRIGGERED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE RV LEAD WAS FOUND TO HAVE HIGH LEAD IMPEDANCE, NO CAPTURE, AND NO SENSING. THE RV LEAD WAS ALSO NOTED TO HAVE INTERMITTENT OVERSENSING, WAS SENSING NOISE, AND WAS SUSPECTED TO BE FRACTURED. THE RV LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RA LEAD HAD LOW LEAD IMPEDANCE, HIGH PACING THRESHOLDS, AND WAS SENSING NOISE. THE RA LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340335 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Hospitalization| R 5076-52 LEAD