BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2812996 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03791
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE DISTAL SEGMENT OF LEAD WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED THE DISTAL CONDUCTOR WAS FRACTURED (IN-VIVO) FLEXED. THE OUTER INSULATION WAS BREACH (IN-VIVO) WITH DEPRESSION.

    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 BY REMOTE TRANSMISSION THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS. THE RIGHT VENTRICULAR LEAD HAD OVER SENSING AND NOISE. THE LEAD WAS EXPLANTED 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB