BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 400 DR

    MDR report key: 7959050 · Received October 11, 2018

    Report

    Report Number
    2182208-2018-01845
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    December 1, 2005
    Report Date
    October 11, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PACEMAKER AUTO-INTERFERENCE BY THORACIC IMPEDANCE MEASUREMENT FOR THE RATE RESPONSE FUNCTION. PACE 2005; 28:1360¿1362. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPGS). THE ARTICLE REPORTS TWO PATIENTS EXPERIENCED ATRIAL OVERSENSING. IT WAS NOTED THAT THE RATE RESPONSE ALGORITHM OF THE PACEMAKER CONTRIBUTED TO THE ATRIAL OVERSENSING OBSERVED AT HIGH RATES. THE IPGS WERE REPROGRAMMED IN ORDER TO AVOID PACEMAKER AUTO-INTERFERENCE CAUSED BY THORACIC IMPEDANCE MEASUREMENTS. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796786 KAPPA 400 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. KDR401

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention 5076 LEAD