BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2953063 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01887
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 22, 2012
    Report Date
    February 11, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. IMPEDANCE/HIGH IMPEDANCE: PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE (B)(6) 2012 15:00:06. DAILY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR SVC DEFIB= 73 TO 230 OHMS PEAK BETWEEN (B)(6) 2012.

    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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD: (B)(6) 2006. 4194 IMPLANTABLE PACING LEAD: (B)(6) 2006. 310F31 IMPLANTABLE TISSUE VALVE: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE DEVICE WAS LATER RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. VISUAL ANALYSIS COMMENTS NOTED NO DAMAGE TO THE CONNECTOR BLOCK OR GROMMETS, AND ALL CONNECTOR BORES WERE FREE OF OBSTRUCTION. WHEN A TEST LEAD WAS INSERTED INTO EACH PORT, THE SETSCREWS WERE TIGHTENED AS EXPECTS AND THE LEADS PASSED A TUG-TEST, HOLDING AS EXPECTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE DAYS OF IMPLANT, THE DEVICE EXHIBITED HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. IT WAS SUSPECTED TO BE RELATED TO THE SETSCREW AND SUBSEQUENTLY, THE SVC COIL WILL BE PROGRAMMED OFF. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE DAYS OF IMPLANT, THE DEVICE EXHIBITED HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. IT WAS SUS PECTED TO BE RELATED TO THE SETSCREW AND SUBSEQUENTLY, THE SVC COIL WILL BE PROGRAMMED OFF. THE DEVICE REMAINS IN USE. NO PATIENTCOMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56079 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention