BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4161765 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02646
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2012
    Report Date
    August 11, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: PARADOXICAL ATRIAL UNDERSENSING BY A DUAL CHAMBER PACEMAKER DURING ATRIAL FIBRILLATION. CARDIOLOGY JOURNAL. 2012;19(2):207-209. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE DESCRIBES ¿ PARADOXICAL ATRIAL UNDERSENSING BY A DUAL CHAMBER PACEMAKER IN A PATIENT WITH PAROXYSMAL ATRIAL FIBRILLATION.¿ ¿ATRIAL UNDERSENSING WAS PRESENT ONLY WHEN THE DEVICE WAS PROGRAMMED TO A HIGH SENSITIVITY, BUT SENSING NORMALIZED WHEN A LOWER SENSITIVITY WAS PROGRAMMED.¿ THE DEVICE REMAINS IN USE AND WAS REPROGRAMMED. 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
    639040 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention