BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA

    MDR report key: 2955383 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02068
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    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
    GA, 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 WHEN THE VENTRICULAR CAPTURE MANAGEMENT RAN ON THE DEVICE THE THRESHOLD WAS 0.875 VOLTS AT 0.4 MILLISECONDS, BUT WHEN THE THRESHOLD WAS CHECKED IN THE CLINIC THE SAME DAY IT WAS 1.75 VOLTS. THE OUTPUT WAS ADJUSTED AND CAPTURE MANAGEMENT WAS REPROGRAMMED TO MONITOR ONLY. THE DEVICE IS STILL 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
    58514 SENSIA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SESR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention 4074 IMPLANTABLE PACING LEAD