BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 3990737 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14398
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    August 1, 2013
    Report Date
    May 15, 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
    MN, 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 PRODUCT: 5076-52, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR APPROXIMATELY 9 MONTHS EARLIER; HOWEVER, THE DEVICE LONGEVITY DURING AN OFFICE VISIT WAS PROJECTED TO BE 18 MONTHS REMAINING. THE DEVICE WAS UPGRADED TO A CRT-D SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472215 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 5076-58 LEAD