BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1874771 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11555
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIROMENTAL STRESS CRACKING, THE OUTER TUBING ENVIROMENTAL STRESS CRACKING BREACH WAS (NON-ELECTRICAL), AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND (B)(4) PROXIMAL SEGMENT

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR LEAD WAS PROPHYLACTICALLY REMOVED. THE PHYSICIAN NOTED A POSSIBLE INSULATION BREACH POST EXPLANT. THE RIGHT VENTRICULAR LEAD WAS PARTIALLY EXPLANTED 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 FIDELIS ASKU LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R 4076 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB