BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2131973 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03546
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE ATRIAL CHANNEL CAUSING MODE SWITCH EPISODES, AND THE LEFT VENTRICULAR 4193 LEAD WAS IN THE ATRIAL PORT. FOLLOW UP WAS CONDUCTED WITH THE PHYSICIAN OFFICE WHICH INDICATED THAT THE DEVICE WAS REPROGRAMMED TO DVIR AND THE LOW RATE WAS DECREASED FROM 80 TO 70 AND THIS SEEMS TO HAVE ADDRESSED THE PROBLEM. PT WAS NOT SYMPTOMATIC AND HAD NO COMPLICATIONS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 5076 IMPLANTABLE PACING LEAD