BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1863376 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11347
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    August 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD DELIVERED NUMEROUS HIGH VOLTAGE (HV) DEFIBRILLATION SHOCKS AND HAD REACHED ITS ELECTIVE REPLACEMENT INTERVAL (ERI) PREMATURELY. THE DEVICE WAS REMOVED AND RETURNED, AND A NEW DEVICE WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) MYOCARDIAL LEAD HAD HIGH PACING THRESHOLDS AND THAT THE DEVICE NEEDED TO BE PROGRAMMED TO AN 8V/1.0M SEC OUTPUT. THE LV LEAD IS STILL IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS 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 59 YR Other| R 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD