BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 1875327 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05476
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 2, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS CONCLUDED WITH NO ANOMALIES FOUND. CORRECTION: ADVERSE EVENT IS YES, PATIENT DEATH IS NOT APPLICABLE.

    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 DURING INTERROGATION OF THE DEVICE THE AAI MODE WAS NOT OFFERED AS AN OPTION WHEN RUNNING AN ATRIAL THRESHOLD TEST. ADDITIONALLY, THE CARDIAC COMPASS REPORT PRINTED HEART RATE VARIABILITY ON A SECOND PAGE RATHER THAN EVERYTHING ON ONE PAGE, AND THERE WAS NO DATA IN THE HEART RATE VARIABLILITY GRAPH. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR ASKU LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 7120 COMPETITOR IMPLANTABLE TACHY LEAD| 7120 COMPETITOR IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD