BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2781641 · Received October 10, 2012

    Report

    Report Number
    2649622-2012-12878
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POCKET REVISION WAS PERFORMED DUE TO PATIENT DISCOMFORT, SHOULDER PAIN AND IRRITATION. THE POCKET WAS REOPENED, A SEGMENT OF THE LEAD WAS REMOVED AFTER THE SCREW WAS RETRACTED AND THE LEAD WAS GENTLY PULLED TO ACCESS POSSIBLE LEAD REMOVAL. THE LEAD WAS THEN CUT AND CAPPED. THE LEAD WAS RETURNED TO THE MANUFACTURER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 7120 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4196 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD