BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 1861644 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04774
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 CAME INTO THE EMERGENCY ROOM "FEELING BAD". A 6 SECOND INTERVAL WITH NO PACING AND THE PATIENT'S INTRINSIC RATE IN THE 40'S OCCURRED. THE DEVICE WAS REPROGRAMMED TO BE LESS SENSITIVE AND THE PATIENT WAS OBSERVED OVERNIGHT, DURING WHICH, THE PATIENT DID NOT HAVE ANY BRADYCARDIA EVENTS. THE PATIENT'S PHYSICIAN ALSO REPORTED THAT THEY HAD RECENTLY STARTED THE PATIENT ON POTASSIUM. THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD