BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA S DR

    MDR report key: 4972147 · Received August 5, 2015

    Report

    Report Number
    3004209178-2015-15299
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 22, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE IDENTIFIED THAT REQUIRED FULL ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANT THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513522 EVERA S DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBC3D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 5076-45 LEAD, 693558 LEAD