BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2201845 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11209
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 LEAD INTEGRITY ALERT TRIGGERED - 1 PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4)-2011 09:33:55. OVERSENSING - THERE WERE 2 VENTRICULAR NST=210 MS AVERAGE V-CYCLE ON (B)(4)-2011 17:59:51 AND (B)(4)-2011 02:27:30. INTERFERENCE/NOISE - VENTRICULAR SHORT INTERVAL COUNT V-SIC=2.1 COUNTS AVG/DAY, IN 138.42 DAYS, BETWEEN (B)(4)-2010 AND (B)(4)-2011 11:08:29.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT TRIGGERED DUE TO SENSING INTEGRITY COUNTS AND NON-SUSTAINED TACHYCARDIA EVENTS. OVERSENSING WAS REPRODUCED WITH ISOMETRIC PATIENT MOVEMENTS. A RIGHT VENTRICULAR LEAD FRACTURE WAS NOTED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB