BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 4163185 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19276
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. CONCOMITANT PRODUCT: 407652, LEAD, IMPLANTED (B)(6) 2014. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT IN FOR A POCKET REVISION ABOUT THREE MONTHS AFTER IMPLANT DUE TO DEVICE MIGRATION AND DEVICE POSITION CAUSING PATIENT DISCOMFORT. 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
    644325 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 407645 LEAD