BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 3050903 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01041
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    January 29, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE A VENTRICULAR LEAD POLARITY SWITCH OCCURRED TRIGGERING A WARNING. 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
    153910 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ RICE CREEK MFG ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1