BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 3050916 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05885
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 2, 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
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCTS: 5054 IMPLANTABLE PACING LEAD (B)(6) 2008, 5568 IMPLANTABLE PACING LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR EARLY. ALSO REPORTED WAS CHRONIC HIGH THRESHOLD OF THE RIGHT VENTRICULAR (RV) LEAD WITH EXIT BLOCK. THE DEVICE AND THE RV LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148619 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R