BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2964489 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02293
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 31, 2012
    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
    FL, 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) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE RIGHT VENTRICULAR (RV) SENSING CIRCUIT AND THE IMPEDANCE WAS JUMPING TO HIGH LEVELS. THE SET SCREW WAS FOUND TO BE FINE AND THE LEAD APPEARED NORMAL THROUGH THE ANALYZER, SO AN UNKNOWN HEADER CONNECTION ISSUE WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67295 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 6935M IMPLANTABLE TACHY LEAD