BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3952684 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13412
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 27, 2014
    Report Date
    August 11, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 PRESENTED TO THE HOSPITAL WITH SYMPTOMATIC BRADYCARDIA AND WAS FOUND TO BE IN SECOND DEGREE HEART B LOCK. THE IPG BATTERY WAS DEPLETED AND THE DEVICE WAS UNABLE TO BE INTERROGATED. THE LEADS WERE TESTED THROUGH THE PACING SYSTEM ANALYZER AND REVEALED HIGH THRESHOLDS AND NO CAPTURE AT MAXIMUM OUTPUT WITH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD AS WELL AS OVERSENSING (TRIPLE SENSING EVERY BEAT) ON THE RA LEAD. THE IPG WAS EXPLANTED AND THE LEADS WERE PARTIALLY EXPLANTED. A NEW IPG SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431256 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR21AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Hospitalization| R 4965-15 LEAD, 4965-15 LEAD