BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 3153695 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08937
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: 4011 IMPLANTABLE PACING LEAD (B)(6) 1987. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYNCOPE AND DIZZINESS ONE WEEK POST ROUTINE GENERATOR CHANGE. THERE WAS A CAPTURE MANAGEMENT AND LEAD WARNING RECORDED IN THE TREND DATA. IT APPEARED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DECREASED TO LOW IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED. IT WAS ALSO NOTED THAT THERE WAS A CAPTURE MANAGEMENT WARNING ON THE IMPLANTABLE PULSE GENERATOR (IPG) AS THE TREND DATA MEASURED HIGHER THAN THE IN-OFFICE TESTS. THE IPG WAS EXPLANTED AND REPLACED SINCE THE LEAD REQUIRED A DIFFERENT CONNECTOR BLOCK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254404 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADSR06

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR