BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3993410 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14625
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. CONCOMITANT PRODUCT: 4076-58 LEAD, IMPLANTED (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DETECTING LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR PORT WHEN CAPTURE WAS ACTUALLY OCCURRING AND CONSEQUENTLY, THE DEVICE HAD AUTOMATICALLY ADJUSTED THE OUTPUT HIGHER THAN NECESSARY. NO LEAD ISSUES WERE NOTED THAT WOULD SUGGESTED AN INTEGRITY ISSUE AND OTHER POTENTIAL CAUSES WERE DISCUSSED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471763 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR 4076-52 LEAD