BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 3993441 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14630
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 PRODUCTS: 6947M55, LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION WAS RECEIVED ONE DAY POST IMPLANT AS THE PATIENT HEARD AN AUDIBLE ALERT. THE ALERT HAD BEEN TRIGGERED FOR LEAD IMPEDANCE WARNING THAT OCCURRED BEFORE THE IMPLANT PROCEDURE. THE DEVICE WAS INTERROGATED AND THE DEVICE WAS REPROGRAMMED. THE ALERT WAS NOTED TO HAVE REOCCURRED AFTER THE PROGRAMMING. 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 ALSO REPORTED THAT THE PATIENT RECEIVED SHOCKS DUE TO POTENTIAL RAPID VENTRICULAR RESPONSE TO FAST ATRIAL RATE. THERE WAS ALSO DISCOMFORT FROM THE IMPLANT. FURTHER, THERE WAS T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469509 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Life Threatening| R 4076-45 LEAD