BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 2955215 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-01868
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 25, 2012
    Report Date
    January 23, 2013
    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
    OK, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD - (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE DAYS OF IMPLANT, THE DEVICE EXHIBITED HIGH RIGHT VENTRICULAR (RV) IMPEDANCES, AS WELL AS AN INCREASE IN R-WAVE MEASUREMENTS, OVERSENSING, AND INCREASED THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE DAYS OF IMPLANT, THE DEVICE EXHIBITED HIGH RIGHT VENTRICULAR (RV) IMPEDANCES, AS WELL AS AN INCREASE IN R-WAVE MEASUREMENTS, OVERSENSING, AND INCREASED THRESHOLDS. 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
    59858 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 6947M IMPLANTABLE TACHY LEAD