BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2953567 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01190
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. IT WAS NOTED THE FIRST, LONGEST AND FASTEST VENTRICULAR HIGH RATE EPISODES HAVE MAXIMUM VENTRICULAR RATES GREATER THAN 400 BEATS PER MINUTE. ONE STORED EPISODE DATED 2012 (B)(6) HAD INTERVALS WITH CYCLE LENGTH LESS THAN 100MS INDICATIVE OF OVERSENSING. THE LOW PACING IMPEDANCE WAS 264 OHMS WITH A LEAD WARNING ON (B)(4) 2012.

    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 PRODUCT: 4076 IMPLANTABLE PACING LEAD 2011-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A LEAD WARNING OCCURRED ON THE ATRIAL AND RIGHT VENTRICULAR LEADS DUE TO OVERSENSING. BOTH LEADS WERE REMOVED AND NEW LEADS WERE IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57478 MEDTRONIC ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)