BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRINSIC

    MDR report key: 2201962 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03849
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 18, 2011
    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
    IL, 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): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED A DIAGNOSTICS PROBLEM WITH A PARITY ERROR COUNT = 1, WITH ADDR = 21BD, DATA = 20, ON (B)(6) 2006 12:22:54.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET (POR). WHEN IT WAS INTERROGATED THERE WERE QUESTION MARKS IN CERTAIN DATA FIELDS. 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 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD