BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3153473 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08916
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD - (B)(6) 2004; 4194 IMPLANTABLE PACING LEAD - (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES, OVERSENSING, AND NOISE WHEN TESTED THROUGH THE DEVICE. THE LEAD WAS TESTED VIA THE ANALYZER, AND EXHIBITED NORMAL SENSING AND IMPEDANCES. THE LEAD WAS TESTED THROUGH THE DEVICE ONCE MORE, WITH SIMILAR RESULTS, EVEN AFTER VERIFYING THAT THE LEAD PIN WAS FULLY INSERTED. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES, OVERSENSING, AND NOISE WHEN TESTED THROUGH THE DEVICE. THE LEAD WAS TESTED VIA THE ANALYZER, AND EXHIBITED NORMAL SENSING AND IMPEDANCES. THE LEAD WAS TESTED THROUGH THE DEVICE ONCE MORE, WITH SIMILAR RESULTS, EVEN AFTER VERIFYING THAT THE LEAD PIN WAS FULLY INSERTED. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256590 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 00071 YR 6944 IMPLANTABLE TACHY LEAD