BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 4162447 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19382
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 MEDICAL PRODUCTS: 1226T, ST JUDE LEAD, IMPLANTED: (B)(6) 1994. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INDICATED 17 MONTHS REMAINING LONGEVITY AND YET TRIPPED THE ELECTIVE REPLACEMENT INDICATOR (ERI) IN FOUR MONTHS. THE DEVICE WAS EXPLANTED 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
    640393 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R 1222 ST JUDE LEAD