BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2811903 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05975
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT PRESENTED TO THE CLINIC BECAUSE THEY "FELT SOMETHING DIFFERENT". THE ATRIAL LEAD VALUES WERE ALL WITHIN NORMAL LIMITS BUT THE ATRIAL CAPTURE MANAGEMENT OUTPUTS HAD INCREASED. THE OUTPUTS ON THE DEVICE WERE REPROGRAMMED AND THE PATIENT COULD NO LONGER FEEL THE PACING. THE DEVICE REMAINS IN USE. NO FURTHER 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. ADDR06

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4) IMPLANTABLE PACING LEAD| 4011 IMPLANTABLE PACING LEAD| (B)(4) MECHANICAL HEART VALVE