BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1921089 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05690
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 7, 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
    FL, 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

    THE PATIENT REPORTED THAT THEY EXPERIENCED AN IRREGULAR HEART RHYTHM, AND THAT THE DEVICE DID NOT RECORD THAT EPISODE. THE DEVICE WAS REPROGRAMMED AND 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 47 YR Required Intervention 5076-1 IMPLANTABLE PACING LEAD| 5076-2 IMPLANTABLE PACING LEAD