BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953012 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00848
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. (B)(4) IMPLANTABLE PULSE GENERATOR 2005 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD TRIGGERED A LEAD WARNING FOR HIGH IMPEDANCE OBSERVED DURING A REMOTE MONITORING TRANSMISSION. DURING AN IN-OFFICE VISIT, UNDEFINED IMPEDANCE WAS NOTED, NO CAPTURE WAS NOTED AT HIGHER OUTPUTS, AND OVERSENSING WAS SEEN. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57702 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO. VILLALBA 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 5568 IMPLANTABLE PACING LEAD