BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 2953536 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01997
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 3, 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
    MI, 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: 5594 IMPLANTABLE PACING LEAD: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT TWO DAYS POST IMPLANT. ON INTERROGATION IT WAS NOTED THAT RIGHT VENTRICULAR IMPEDANCE WAS HIGH, THERE WAS NO VENTRICULAR CAPTURE, THERE WERE SHORT INTERVAL COUNTS, AND THERE WAS OVERSENSING IN THE ATRIAL CHANNEL. THE POCKET WAS OPENED AND IT WAS DETERMINED THAT THE SET SCREWS WERE LOOSE AND THERE WAS FLUID IN THE HEADER. THE LEADS WERE REMOVED AND REINSERTED, AND THE SET SCREWS WERE TIGHTENED BACK DOWN, WHICH RESOLVED THE ISSUES. THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO REPOSITIONED TO OBTAIN BETTER R WAVES. THE LEADS 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
    56257 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| R 6935M IMPLANTABLE TACHY LEAD