BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 2527117 · Received April 11, 2012

    Report

    Report Number
    6000144-2012-01817
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    January 10, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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. IT WAS NOTED THAT A POWER ON RESET (POR) FOR WRITE TO LOCKED RAM, ADDR=17EF, DATA=24 OCCURRED ON (B)(4) 2012 02:36:41. THERE WAS 1 - PATIENT ALERT FOR POR ON (B)(4) 2012 02:36:41. DIAGNOSTIC INFORMATION IS CONSISTENT WITH REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THE DEVICE BEEPING. UPON INTERROGATION, IT WAS NOTED THAT AN ELECTRICAL RESET HAD OCCURRED. THE DEVICE WAS CLEARED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7278

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 0158 COMPETITOR IMPLANTABLE TACHY LEAD| 1388TC COMPETITOR IMPLANTABLE PACING LEAD| 6996 IMPLANTABLE TACHY LEAD