BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE DR

    MDR report key: 3993028 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14712
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 19, 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
    NJ, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS : 5076-52, LEAD, IMPLANTED (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM FEELING WEAK AND EXHAUSTED. THE DEVICE WAS INTERROGATED AND IT WAS DISCOVERED THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS. THE PATIENT STATED THEY SUFFERED A STROKE AND ATTRIBUTED IT TO THE DEVICE SWITCHING TO VVI PACING WHEN IT WENT TO ERI. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472728 ENPULSE DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO E2DR01AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L| R 5024M-58 LEAD