BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1860981 · Received October 7, 2010

    Report

    Report Number
    2182208-2010-00773
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 19, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED. PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THE VENTRICULAR SHORT INTERVAL COUNT V-SIC=76.1 COUNTS AVG/DAY, IN 3.18 DAYS, BETWEEN (B)(6) 2010 10:40:32. MANUFACTURING SITE # WAS NOT PULLED IN FROM EARS. GENERIC MEDTRONIC, INC SITE WAS SELECTED ON DEVICE TAB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FALSE SENSING DURING ONE OF THE OBSERVED EPISODES AND THE SENSING INTEGRITY COUNTER WAS HIGH INDICATING OVERSENSING. THE IMPEDANCES WERE IN THE NORMAL RANGE AND NO NST'S WERE OBSERVED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FALSE SENSING DURING ONE OF THE OBSERVED EPISODES AND THE SENSING INTEGRITY COUNTER WAS HIGH INDICATING OVERSENSING. THE IMPEDANCES WERE IN THE NORMAL RANGE AND NO NON-SUSTAINED TACHYCARDIA'S WERE OBSERVED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 7279 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7279 IMPLANTABLE PACEMAKER/CARDIO/DEFIB