BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA SR

    MDR report key: 2131622 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03529
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    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 Location
    HI, US
    Reporter Occupation
    PATIENT

    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

    PATIENT STATED, "I HAVE A HEART MURMUR THAT WASN'T THERE BEFORE. I AM DIZZY, WEAK, FAINT, BLACKING OUT, AND MY CHEST IS BURNING." PATIENT ALSO STATED "I WANT THE PACEMAKER SHUT OFF, IT IS BURNING ME. I FAINT AND BLACK OUT MORE OFTEN." PATIENT WENT TO THE ER AND STATED THAT HER HEART IS AT 0 AT TIMES EVEN WITH THE PACEMAKER. 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 48 YR Other 5076 IMPLANTABLE PACING LEAD