BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 3152474 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09031
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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 PRODUCTS: 4568-53 IMPLANTABLE PACING LEAD - (B)(6) 2001; 4068-58 IMPLANTABLE PACING LEAD - (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD LOW IMPEDANCE AND WAS NOT SENSING. IT WAS NOTED THAT THE UNIPOLAR IMPEDANCE OF THE ATRIAL LEAD WAS HIGHER THAN THE BIPOLAR IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD'S THRESHOLDS WERE HIGH, AND THAT THE DEVICE HAD AN EGM ISSUE WHICH COULD BE THE DEVICE ADC (ANALOG TO DIGITAL CONVERTER). THE SYSTEM (ATRIAL LEAD, RV LEAD, AND 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
    252828 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR