BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3990074 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-14491
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 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
    CT, 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. PRODUCT ID 4092-58 LEAD IMPLANTED: 2004 (B)(6). (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 DEVICE WAS AT END OF SERVICE (EOS) AND COULD NO LONGER BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT DURING THE DEVICE REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE AND INTERMITTENT CAPTURE AT 5 VOLTS. A FRACTURE WAS SUSPECTED BUT COULD NOT BE CONFIRMED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462670 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 4592-53 LEAD