BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 1792331 · Received August 11, 2010

    Report

    Report Number
    6000144-2010-03213
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    May 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 A COUPLE OF WEEKS AFTER RATE RESPONSE SETTINGS WERE ADJUSTED, THE PATIENT NOW FEELS LIGHHEADED AND FEELS HIS HEART BEATING FAST. THE ADJUSTMENT WAS FROM ACTIVITIES OF DAILY LIVING (ADL) OF 3 TO ADL OF 5, AND ADL RATE OF 95 TO ADL RATE OF 105 BEATS PER MINUTE. THE PHYSICIAN INTENDS TO CHANGE PROGRAMMING BACK TO ADL OF 3, AND ADL RATE OF 95 BEATS PER MINUTE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention 5076 IMPLANTABLE PACING LEAD