BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2790017 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05396
    Event Type
    Injury
    Date Received
    October 15, 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
    VA, 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 THE DEVICE CAPTURE MANAGEMENT ALGORITHM WAS SUSPECTED OF HAVING RAISED THE LEAD OUTPUTS DUE TO EVOKED RESPONSE UNDERSENSING. 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. ADDR03

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| UNKOLDLD IMPLANTABLE PACING LEAD