BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 3991300 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14313
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 1, 2013
    Report Date
    June 9, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY:THE DEVICE WAS RETURNED AND ANALYSIS REVEALED NO ANOMALIES AND NO ISSUE IDENTIFIED THAT REQUIRED FULL ANALYSIS.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BURNING SENSATION IN THE POCKET IMMEDIATELY AFTER DEVICE IMPLANT. IT WAS ALSO REPORTED THAT ATRIAL LEAD DISLODGEMENT WAS NOTED DURING FOLLOW-UP APPROXIMATELY A YEAR AFTER IMPLANT. THE LEAD AND THE DEVICE WERE BOTH REMOVED AND REPLACED. DUE TO THE ATRIAL LEAD DISLODGEMENT THE PATIENT HAD SYMPTOMS OF LIGHTHEADEDNESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468313 VERSA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5076-52 LEAD, 5076-58 LEAD