BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 3992952 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14725
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REPORTED A HIGH VENTRICULAR THRESHOLD. IN OFFICE MANUAL THRESHOLD TEST WAS 0.5 VOLTS. AN IN OFFICE VENTRICULAR CAPTURE MANAGEMENT TEST WAS PERFORMED AND HAD A HIGH THRESHOLD. THE MANUAL THRESHOLD TEST WAS PERFORMED AGAIN WITH THE SAME RESULT. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467634 SENSIA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention 5076-52 LEAD