BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2131329 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03460
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 1, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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 THE PATIENT WAS EXPERIENCING AN IRREGULAR AND FAST HEART RATE AND WAS NOT FEELING WELL AND WAS WONDERING IF THE DEVICE BATTERY WAS DEAD. FOLLOW UP INFORMATION WAS OBTAINED AND INDICATED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AND THE DEVICE WAS REPROGRAMMED. 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
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other 4592 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD