BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 1990342 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00700
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 8, 2010
    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
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CRITICAL RAM PARITY ERROR LOGGED ON (B)(6) 2010. THIS COINCIDES WITH THE INSTALL TIMESTAMP OF SYSTEM SOFTWARE UPDATE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POWER ON RESET (POR) OCCURRED IN PATIENT'S PACEMAKER. THIS WAS "NOT A CRITICAL POR." DEVICE WAS INTERROGATED, RESET, AND IS WORKING APPROPRIATELY. THE PACEMAKER REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POWER ON REST (POR) OCCURRED IN PATIENT'S PACEMAKER. THIS WAS "NOT A CRITICAL POR." DEVICE WAS INTERROGATED, RESET, AND IS WORKING APPROPRIATELY. THE PACEMAKER REMAINS IN USE. NO PATIENT COMPLICATIONS WERE 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 76 YR Required Intervention 5076 X2 IMPLANTABLE PACING LEAD| 5076 X2 IMPLANTABLE PACING LEAD| (B)(4) TISSUE VALVE| (B)(4) TISSUE VALVE