BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1924390 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06131
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS INDICATES THAT BATTERY DEPLETION/ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOTED ON (B)(6) 2010. A MEASUREMENT SYSTEM LOCK-UP ERROR OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOTED ON TRANSTELEPHONIC MONITORING (TTM) AND THE BATTERY VOLTAGE AND LEAD MEASUREMENTS COULD NOT BE COMPLETED. IT WAS QUESTIONED IF THE DEVICE WAS TRULY AT ERI OR IF THERE WAS A SOFTWARE PROBLEM. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE 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 MED REL, INC. ADDR06 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 4011 IMPLANTABLE PACING LEAD| 4511 IMPLANTABLE PACING LEAD