BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1992546 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02908
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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): ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) EPICARDIAL LEAD WAS FOUND TO HAVE A HIGH THRESHOLD/UNMEASURABLE. THE LEAD WAS CAPPED AND ANOTHER LV EPICARDIAL LEAD PREVIOUSLY IMPLANTED IS NOW BEING USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) EPICARDIAL LEAD WAS FOUND TO HAVE A HIGH THRESHOLD/UNMEASURABLE. THE LEAD WAS CAPPED AND ANOTHER LV EPICARDIAL LEAD PREVIOUSLY IMPLANTED IS NOW BEING USED. THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5071 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5071 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB