BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 4160854 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19068
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    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
    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 MEDICAL PRODUCT : 4296-78, LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING AND AN ALERT WAS TRIGGERED FOR NON-SUSTAINED TACHYCARDIA (NST) EPISODES AND SHORT INTERVAL COUNTS (SIC). THE LEAD IMPEDANCE WAS NOTED TO BE STABLE AND THE LEAD REMAINED IN USE. IT WAS LATER REPORTED THAT THE POCKET WAS OPENED TO INSPECT THE LEAD FOR ONGOING NOISE REPRODUCED WITH POCKET MANIPULATION. THE RV LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD HAD VISIBLE INSULATION DAMAGE. THE LV LEAD WAS EXPLANTED AND REPLACED. ADDITIONALLY, THE DEVICE SEEMED TO HAVE A SENSING/DETECTION PROBLEM SO THE PHYSICIAN REQUESTED A NEW DEVICE, AND EXPLANTED AND REPLACED THE OLD DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642227 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 00069 YR Hospitalization| R 6935-58 LEAD