BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2812216 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15916
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. IT WAS NOTED THAT THERE WAS BLOOD (NOT OBSTRUCTED) ON THE PROXIMAL AND DISTAL CONDUCTORS, THE OUTER INSULATION HAD COSMETIC DEPRESSION AND THE OUTER INSULATION OVERLAY TUBING HAD ENVIRONMENTAL STRESS CRACKING.

    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 RIGHT VENTRICULAR (RV) LEAD HAD AN INCREASE IN IMPEDANCE WHICH IS NOW HIGH AND TRIGGERED AN ALERT. IMPEDANCES IN THE CLINIC DURING ISOMETRICS WERE "WIDELY VARIANT" AND UPON INTERROGATION RV CAPTURE INCREASED WHICH INDICATED LEAD FRACTURE. THE LEAD WAS CAPPED AND 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB