BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 4162641 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19355
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-2120-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCT: ICF09B45 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CALLED AND REPORTED THAT THEY THINK SOMETHING IS GOING ON WITH THEIR PACEMAKER THE PAST FEW DAYS, THEY FEEL FUNNY, AND THEIR HEART IS BEATING TOO FAST INTERMITTENTLY. FOLLOW-UP WAS CONDUCTED WITH THE CLINIC AND THE PATIENT HAS BEEN NON-COMPLIANT WITH THEIR FOLLOW-UP. THE PATIENT WAS LAST SEEN BY THEIR PHYSICIAN IN (B)(6) 2011. 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
    644369 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR IMK49B52 LEAD