BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2451735 · Received February 14, 2012

    Report

    Report Number
    6000144-2012-00807
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    August 15, 2011
    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
    CA, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. POWER ON RESET PARAMETERS (POR) WERE NOTED AS TWO POR'S FOR WRITE TO LOCKED RAM, OCCURRED ON (B)(4)-2011 18:17:46 AND (B)(4)-2011 16:01:59. ONE PATIENT ALERT FOR POR OCCURRED ON (B)(4)-2011 16:01:59.

    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. POWER ON RESET PARAMETERS (POR) WERE NOTED AS TWO POR'S FOR WRITE TO LOCKED RAM, OCCURRED ON (B)(4) 2011 18:17:46 AND (B)(4) 2011 16:01:59. ONE PATIENT ALERT FOR POR OCCURRED ON (B)(4) 2011 16:01:59. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. A RANDOM ACCESS MEMORY (RAM) CHIP MEMORY ERROR WAS FOUND IN THE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD TWO POWER ON RESETS. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT DUE TO THE PATIENT'S ANXIETY AND MEDICAL JUDGMENT, THE DEVICE WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD TWO POWER ON RESETS. THE DEVICE WAS REPROGRAMMED 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 VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD