BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2042659 · Received April 6, 2011

    Report

    Report Number
    2647346-2011-00421
    Event Type
    Injury
    Date Received
    April 6, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED TO THE LAB WITH NO INFORMATION. THE ELECTIVE REPLACEMENT INDICATOR (ERI) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THE BATTERY TELEMETERED VALUE MEASURED 2.81 VOLTS. THE BATTERY MEASURED A TELEMETERED VALUE OF 2.14 VOLTS LOADED. CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD NOT MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI WAS THE RESULT OF A DELTA V READING GREATER THAN .211 V. ERI OCCURRED (B)(6) 2010 WHICH IS BEFORE EXPLANT. THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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 11 YR Hospitalization| R 4968 IMPLANTABLE PACING LEAD