BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 1854813 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04386
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 THE PATIENT WAS "FEELING ILL" DURING CARDIAC REHABILITATION EXERCISE AND HAD LOW BLOOD PRESSURE AND REDUCED HEART RATE. THE DEVICE REMAINS ACTIVE. 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 61 YR Other 5076-45 IMPLANTABLE PACING LEAD| 5076-52 IMPLANTABLE PACING LEAD