BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 3152308 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09062
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 29, 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
    NM, 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. A 6935M IMPLANTABLE TACHY LEAD, (B)(6) 2013. A 4194 IMPLANTABLE PACING LEAD, (B)(6) 2007. A 5076 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS NOTED ON THE RIGHT VENTRICULAR LEAD ONE DAY POST IMPLANT. THE LEAD AND SET SCREWS WERE RECONNECTED. BOTH THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252834 PROTECTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R