BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRINSIC

    MDR report key: 1854978 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04288
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. PRIMARY ANALYSIS FINDING: POWER ON RESET PARAMETERS WERE NOTED. POWER ON RESET DUE TO WRITE TO LOCKED RAM OCCURED ON 06, AUG. 2010. POWER ON RESET SEVERITY LOW, DEVICE SHOULD BE ABLE TO RECOVER AFTER RESET.

    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. PRIMARY ANALYSIS FINDING: POWER ON RESET PARAMETERS WERE NOTED. POWER ON RESET DUE TO WRITE TO LOCKED RANDOM ACCESS MEMORY (RAM) OCCURED ON (B)(6) 2010. POWER ON RESET SEVERITY LOW, DEVICE SHOULD BE ABLE TO RECOVER AFTER RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC ASKU LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 6940 IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD| 6945 IMPLANTABLE TACHY LEAD| 6940 IMPLANTABLE PACING LEAD