BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3152322 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06854
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT: KDR931J IMPLANTABLE PACEMAKER (B)(6) 2006. CONCOMITANT PRODUCT: 5554 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD WARNING FOR LOW RIGHT VENTRICULAR (RV) LEAD IMPEDANCE. IT WAS ALSO REPORTED THAT A PACING FAILURE, OVERSENSING AND NOISE WAS CONFIRMED WITH THE RV LEAD. A PARAMETER CHANGE INITIAL RESOLVED THE RV PACING FAILURE; HOWEVER THE RV LEAD WAS LATER REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252914 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R