BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1990449 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00730
    Event Type
    Injury
    Date Received
    February 15, 2011
    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
    TN, 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) THE DEVICE WAS RETURNED, ANALYZED, AND HIGH BATTERY IMPEDANCE WAS FOUND. PERFORMANCE WAS DATA COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS RESULTS REVEALED THE PRESENCE OF POWER ON RESET PARAMETERS. A CRITICAL RAM PARITY ERROR WAS LOGGED ON (B)(4) 2010. THIS COINCIDES WITH THE INSTALL TIME STAMP OF RAMWARE.

    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) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED THE PRESENCE OF POWER ON RESET PARAMETERS. A CRITICAL RAM PARITY ERROR WAS LOGGED ON (B)(4) 2010. THIS COINCIDES WITH THE INSTALL TIMESTAMP OF RAMWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN ELECTRICAL RESET AND THEN DEVICE TRIPPED ELECTIVE REPLACEMENT INDICATOR. THE PACEMAKER WAS 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 88 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD