BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2812341 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15686
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. NO ANOMALIES WERE FOUND. THE DEFIB CONDUCTOR WAS DISTORTED. SEVERAL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY HAD BLOOD/BODY FLUID, WAS MELTED, AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THE INNER INSULATION WAS MELTED. THE OUTER INSULATION WAS MELTED, HAD A WHITE SUBSTANCE, AND HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND HELIX/LOBE MECHANISM (SLEEVE HEAD). VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS WITH NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER 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 PUERTO RICO, INC. 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5568 IMPLANTABLE PACING LEAD| 37712 PAIN STIM IPG| 3777 X2IMPLANTABLE PAIN STIMULATOR LEAD