BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1925848 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06354
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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. ANALYSIS CONCLUDED THAT NO ANOMALIES COULD BE FOUND. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.78 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.89 V. THIS DIFFERENCE IS WITHIN EXPECTATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON INTERROGATION IN CLINIC THE BATTERY GAVE LOW READINGS AND DIFFERENT READINGS THAN AT A PREVIOUS INTERROGATION THAT DAY. BATTERY MEASUREMENTS WERE SENT TO THE CALLER. THE DEVICE REMAINS 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other 5554 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD