BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1924114 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06088
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 17, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 DURING IMPLANT THE DEVICE WAS NOT PACING. UPON CONNECTING THE DEVICE TO THE VENTRICULAR LEAD OF THE PACEMAKER OUTSIDE OF THE POCKET, THE PHYSICIAN NOTED THAT IT WAS NOT PACING. THE PHYSICIAN CONNECTED THE LEADS BACK TO THE ANALYZER AND THE PHYSICIAN TOLD THE MEDTRONIC REPRESENTATIVE THAT THE DEVICE WAS BAD. A NEW DEVICE WAS IMPLANTED AND WORKED FINE. NO PATIENT COMPLICATIONS WERE 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 MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other