BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENRHYTHM DR

    MDR report key: 1921087 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05689
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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 INDICATED - BATTERY VOLTAGE - LOW TELEMETERED BATTERY VOLTAGE. ON (B)(6) 2010, THE TELEMETERED BATTERY VOLTAGE WAS 2.23 V WHILE THE DAILY BATTERY VOLTAGE TREND MEASUREMENT WAS 2.90 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY VOLTAGE MEASUREMENT WAS BELOW THE ELECTIVE REPLACEMENT INDICATOR LEVEL (ERI), BUT THE DEVICE ERI HAD NOT TRIGGERED AND THAT THERE WERE INCONSISTENT BATTERY VOLTAGE MEASUREMENTS. THE DEVICE IS STILL 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 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 5568 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD