BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2122295 · Received June 13, 2011

    Report

    Report Number
    6000144-2011-02152
    Event Type
    Injury
    Date Received
    June 13, 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
    NJ, US
    Reporter Occupation
    OTHER

    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 SINCE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) THE PATIENT REPORTED SHORTNESS OF BREATH (SOB) AND IS EXPERIENCING "SOME IRREGULAR HEART RATE AT NIGHT AND PULSING AND POUNDING." IT WAS FURTHER REPORTED BY THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PERFORMANCE ISSUE WITH THE DEVICE, HOWEVER PATIENT SYMPTOMS WERE DUE TO HIGH BLOOD PRESSURE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A QUESTION REGARDING THE DEVICE RATE RESPONSE FEATURE; REPORTS FEELING FATIGUED AND HAS HEARD FAST HEART RATE AT TIMES WHEN FALLING ASLEEP AND FEEL HEART RATE IS TOO FAST FOR ACTIVITY DOING AT THE TIME. A PROGRAMMING ADJUSTMENT TO THE IPG TOOK PLACE AND THE DEVICE 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
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention 1246T COMPETITOR IMPLANTABLE PACING LEAD| 1242T COMPETITOR IMPLANTABLE PACING LEAD