BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 3152782 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08840
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MEDICAL PRODUCTS: 6949 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2006. 4194 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2006. 4076 IMPLANTABLE PACING LEAD: IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK AFTER PATIENT RECEIVED A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE DOCTOR HAD TO OPEN THE POCKET TO EVACUATE A HEMATOMA. THE PATIENT¿S CURRENT DEVICE WOULD LIKELY BE EXTRACTED DUE TO WOUND BEING OPEN. 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
    257458 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention