BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA CRT-D

    MDR report key: 3152352 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09049
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2002; 4549 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2013; 5568 IMPLANTABLE PACING LEAD (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEWLY IMPLANTED DEVICE HAS NOISE ON THE CAN TO RIGHT VENTRICULAR (RV) COIL RESULTING IN THE ABILITY TO OBTAIN CLEAN ELECTROGRAM (EGM) SIGNAL FOR WAVELET USING CAN TO RV COIL VECTOR. IT WAS ALSO REPORTED THAT DEFIBRILLATION THRESHOLDS (DFTS) WERE PERFORMED WITH FAILURE TO RESCUE THE PATIENT AND FLUOROSCOPY SHOWED THAT THE LEAD PIN WERE IN THE CORRECT LOCATION IN THE HEADER. FURTHER TESTING INCLUDING ISOMETRIC EXERCISES AND POCKET MANIPULATION WHILE PERFORMING LEAD IMPEDANCES TOGETHER WITH CLOSER MONITORING WAS RECOMMENDED. THE RV LEAD AND DEVICE REMAIN 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
    252944 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 00086 YR Required Intervention