BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1874794 · Received October 19, 2010

    Report

    Report Number
    2182208-2010-00823
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THERE WAS A SPECIFIC ISSUE THAT HAS BEEN OCCURRING IN PATIENTS WITH AN (B)(4), OR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WILL HAVE AN EVENT THAT RESULTS IN A RETROGRADE P-WAVE, WHICH IN TURN RESULTS IN ATRIAL PACING (AP) THAT TIMES OUT WITH NO CAPTURE, AND VENTRICULAR PACING (VP) THAT ALSO TIMES OUT. THIS RESULTS IN ANOTHER RETROGRADE P-WAVE, AND THE CYCLE CONTINUES. THE PHYSICIAN RECOMMENDS HAVING THE "SHORT ATRIOVENTRICULAR (AV) INTERVAL" PROGRAMMABLE. HE BELIEVES THAT IF THE AV INTERVAL WAS PROLONGED, IT WOULD POSSIBLY ALLOW R-WAVES THAT WOULDN'T CAUSE THE UNNECESSARY RIGHT VENTRICULAR (RV) PACING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other