BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1922832 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02224
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 5, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION WAS INDICATED/ELECTIVE REPLACEMENT INDICATOR. A MEASUREMENT SYSTEM LOCK-UP ERROR OCCURRED. ELECTIVE REPLACEMENT INDICATOR WAS RECORDED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR, PACING VVI 65 BPM, BATTERY/LEAD MEASUREMENTS WERE NOT DISPLAYED, AND THERE WAS POSSIBLE PREMATURE BATTERY DEPLETION. TURNING THE PROGRAMMER OFF AND ON, AND RE-INTERROGATING THE DEVICE DID NOT RESOLVE THE ISSUE. AFTER THE MANUFACTURER'S TECHNICAL REPRESENTATIVES EXAMINED THE DEVICE PERFORMANCE DATA, IT WAS DETERMINED THAT THE ISSUE COULD BE CORRECTED THROUGH A PROGRAMMING AND THAT A DEVICE REPLACEMENT WAS NOT NEEDED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention