BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1861652 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04770
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION SUMMARY: (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TELEMETERED BATTERY VOLTAGE WAS 2.78 V ON (B)(6) 2010 AND WAS 2.96 V ON THE SAME DAY IN THE DAILY BATTERY VOLTAGE TREND CHART. PRELIMINARY ANALYSIS FOUND THAT THE BATTERY TELEMETERED VALUE MEASURED 2.59 VOLTS. CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% LONGEVITY. FURTHER ANALYSIS OF THE BATTERY CELL INDICATED THAT IT WAS NOT DEPLETED, BUT IT WAS FOUND TO HAVE INTERNAL RESISTANCE EXCEEDING THE SPECIFICATION LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR) AND THERE WAS CONCERN ABOUT SHORT LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. 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 87 YR Required Intervention 4076 (X2) IMPLANTABLE PACING LEADS