BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO DR

    MDR report key: 2370610 · Received December 13, 2011

    Report

    Report Number
    6000144-2011-07122
    Event Type
    Malfunction
    Date Received
    December 13, 2011
    Date of Event
    August 22, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    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. ONE POR FOR WRITE TO LOCKED RAM, ADDR=15A5, DATA=59, OCCURRED ON (B)(6) 2011 16:57:21. ONE PATIENT ALERT FOR POR OCCURRED ON (B)(6) 2011 16:57:21.

    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. ONE POR FOR WRITE TO LOCKED RAM, ADDR=15A5, DATA=59, OCCURED ON (B)(4) 2011 16:57:21. ONE PATIENT ALERT FOR POR OCCURRED ON (B)(4) 2011 16:57:21.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A POR (POWER ON RESET) DURING THE PATIENT'S RADIATION THERAPY. FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT NO REPROGRAMMING OF THE DEVICE WAS NECESSARY. THE DEVICE STILL 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 THE DEVICE HAD A POR (POWER ON RESET) DURING THE PATIENT'S RADIATION THERAPY. FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT NO REPROGRAMMING OF THE DEVICE WAS NECESSARY. IT WAS FURTHER REPORTED THAT THE DEVICE'S DIAGNOSTICS REPORTED INVALID. THE DEVICE STILL 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 89 YR Other 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD