BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA

    MDR report key: 1874788 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05421
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    April 12, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CORRECTED: OPERATOR, OTHER DEVICES. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE UPGRADE FOR A DEVICE AT ELECTIVE REPLACEMENT (ERI), THE NEW DEVICE APPEARED TO HAVE STRIPPED SET SCREWS. THE NEW DEVICE WAS NOT USED. ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE UPGRADE FOR A DEVICE AT ELECTIVE REPLACEMENT (ERI), THE NEW DEVICE APPEARED TO HAVE STRIPPED SET SCREWS. THE NEW DEVICE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other 6942 IMPLANTABLE TACHY LEAD| 6940 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE TACHY LEAD| 6942 IMPLANTABLE TACHY LEAD