BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2200530 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11001
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    March 8, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 MORNING POST IMPLANT PROCEDURE THE PATIENT'S CHEST X-RAY DEMONSTRATED A MODERATE SIZED PNEUMOTHORAX. A CHEST TUBE WAS PUT IN PLACE AND THE PNEUMOTHORAX WAS RESOLVED. ADDITIONAL INFORMATION RECEIVED FROM FOLLOW-UP STATES THAT THE PNEUMOTHORAX IS RELATED TO THE IMPLANT PROCEDURE AND HAS INDICATED THAT IT IS NOT RELATED TO ANY SYSTEM COMPONENT. THE RIGHT VENTRICULAR LEAD IS STILL IN USE. IT WAS ALSO REPORTED THAT THE PATIENT HAD LEFT SIDED CHEST PAIN AND A FEELING OF THE HEART THUMPING. THE OUTPUTS WERE ADJUSTED FOR THE LEAD TO DECREASE THE DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS PART OF THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R 5076 (X2) IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 (X2) IMPLANTABLE PACING LEAD