BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 1922714 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05975
    Event Type
    Injury
    Date Received
    December 13, 2010
    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
    CA, 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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT'S FOLLOW-UP, THE DEVICE WAS PACING AT AN INAPPROPRIATELY HIGH RATE. MULTIPLE PROGRAMMING ATTEMPTS COULD NOT RESOLVE THIS ISSUE WHEN THE DEVICE WAS IN A RATE RESPONSIVE (RR) MODE. IT WAS ALSO REPORTED THAT BOTH THE ATRIAL AND VENTRICULAR PACING LEADS HAD HIGH PACING THRESHOLDS. THE DEVICE WAS REMOVED AND REPLACED. BOTH LEADS WERE SUCCESSFULLY REPOSITIONED AND ARE STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS 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 85 YR Hospitalization| R