BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 1925443 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06316
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED THAT A POWER ON RESET (POR) OCCURRED ON (B)(6) 2010. ONE PATIENT ALERT FOR POR ON OCCURRED ON (B)(6) 2010. THE DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE REPORTED EVENT.

    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 A POWER ON RESET OCCURRED. ALL THE DIAGNOSTICS WERE CLEARED AND DEVICE PARAMETERS WERE REPROGRAMMED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET OCCURED. ALL THE DIAGNOSTICS WERE CLEARED AND DEVICE PARAMETERS WERE REPROGRAMMED. THE DEVICE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 5034 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5034 IMPLANTABLE PACING LEAD