BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 2051692 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01540
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    December 7, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    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.

    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 REVEALED A WRITE TO LOCKED RAM POWER ON RESET OCCURRED ON (B)(4) 2010. THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER THE RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HAVING HIGH ATRIAL RATES. POWER-ON-RESET PARAMETERS WERE REPORTED, INCLUDING "WRITE TO LOCKED RAM" ERROR. THE DEVICE WAS REPROGRAMMED TO NORMAL SETTINGS AND THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R 5554 IMPLANTABLE PACING LEAD| 5554 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD| 6948 IMPLANTABLE TACHY LEAD