BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 4162822 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19329
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 19, 2012
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 MEDICAL PRODUCTS: 5076 LEAD, IMPLANTED (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER IMPLANT OF THE DEVICE, THE PATIENT DEVELOPED A SMALL PNEUMOTHORAX. THE PATIENT REMAINED ASYMPTOMATIC AND WAS SATURATED ON ROOM AIR 98-99% THROUGHOUT THE HOSPITAL STAY. THE DEVICE REMAINS IN USE. THE PATIENT IS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640236 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L 6947 LEAD