BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3992078 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14920
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    January 16, 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
    OH, 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 PRODUCTS: PRODUCT ID: 694965, LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD IMPEDANCE WARNING AND THE PATIENT WENT TO THE EMERGENCY ROOM WHEN RECEIVING INAPPROPRIATE THERAPY DUE TO THE RIGHT VENTRICULAR (RV) LEAD HAVING NOISE. LEAD FRACTURE WAS ALSO REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS TWOS (T-WAVE OVERSENSING). THE RV LEAD WAS PROGRAMMED OFF, AND A FEW DAYS LATER EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE DEVICE DELIVERED INAPPROPRIATE THERAPY WHEN THE DEVICE FEATURE WAS PROGRAMMED ON TO AVOID INAPPROPRIATE THERAPY. THE DEVICE REMAINS 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
    471022 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R 5076-52, LEAD