BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA

    MDR report key: 2938428 · Received January 31, 2013

    Report

    Report Number
    3004209178-2013-01207
    Event Type
    Injury
    Date Received
    January 31, 2013
    Report Date
    September 3, 2010
    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

    (B)(4). THESE EVENTS WERE REPORTED TO FDA ON JANUARY 31, 2013 WITHIN A RETROSPECTIVE SUMMARY REPORT. THE FDA APPROVAL NUMBER FOR THIS SUMMARY REPORT IS (B)(4). THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED FOR PRODUCT CODE NVZ IS 234, INCLUDING THE 3500A EVENT AND EVENTS DETAILED IN THE XLS. THIS RETROSPECTIVE REVIEW WAS PERFORMED FOLLOWING OUR FIRM'S CHANGE IN MEDICAL DEVICE REPORTING CRITERIA. THESE REPORTS REPRESENT EVENTS WITH ALERT DATES IN THE TWO YEARS PRIOR TO THAT CHANGE IN REPORTING CRITERIA. PLEASE NOTE THAT INCLUDED IN THIS RETROSPECTIVE SUMMARY REPORT ARE THE RELEVANT EVENTS FOR PRODUCT CODE DXY. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076-52, IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR PACING LEAD HAD HIGH THRESHOLDS WHICH LED TO INCREASED BATTERY DEPLETION ON THEIR DEVICE. THE LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS EXPLANTED DUE TO EARLY BATTERY DEPLETION AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42435 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 4092-58 IMPLANTABLE PACING LEAD| 4092-58 IMPLANTABLE PACING LEAD