BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1791169 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03125
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    March 19, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY: (B)(4) PRIMARY ANALYSIS FINDING: THE DEVICE DID NOT MEET ITS 99.9% OF ITS EXPECTED LONGEVITY. BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE AT RECEIVED AND BOL (BEGINNING OF LIFE) VOLTAGES. THERE IS NO EVIDENCE TO INDICATE A PROBLEM WITH THE BATTERY. WITHOUT KNOWING THE PROGRAMMING HISTORY OF THIS DEVICE THERE IS NO WAY TO DETERMINE WHY IT DID NOT MEET ITS EXPECTED LONGEVITY CALCULATION.

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY: EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. FOLLOW-UP WITH THE HCP INDICATED THE DEVICE WAS REPLACED DUE TO EOL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO INFORMATION WAS PROVIDED AS TO WHY THE DEVICE WAS REPLACED. EFFORTS TO CONTACT THE PHYSICIAN/HOSPITAL REGARDING THIS EVENT ARE IN PROCESS AT THIS TIME. 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 94 YR Hospitalization| O| R 5034 IMPLANTABLE PACING LEAD| 4568 IMPLANTABLE PACING LEAD| 5034 IMPLANTABLE PACING LEAD| 5034 IMPLANTABLE PACING LEAD| 4568 IMPLANTABLE PACING LEAD| 4568 IMPLANTABLE PACING LEAD