BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1992663 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02976
    Event Type
    Injury
    Date Received
    February 15, 2011
    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
    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 DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DEFIB CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS MELTED AND HAD A COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC), AND ESC BREACH (NON-ELECTRICAL). THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND APPARENT EXPLANT DAMAGE. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    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 SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DEFIB CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS MELTED AND HAD A COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC), AND ESC BREACH (NON-ELECTRICAL). THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND APPARENT EXPLANT DAMAGE. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. (B)(4): THE INITIAL REPORT OF INFECTION FOR THIS DEVICE WAS RECEIVED ON (B)(6) 2010 AND IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORTING (ASR). INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 THAT REVEALED AN OUT OF SPEC ANALYSIS FOR THIS DEVICE. AS THERE IS NEW INFORMATION, THIS DEVICE NO LONGER QUALIFIES FOR ASR, AND IS THEREFORE BEING ADDED TO THIS BIMONTHLY REPORT. EVALUATION SUMMARY: THE DEVICE PASSED PRELIMINARY ANALYSIS. A SUBSEQUENT FUNCTIONAL TEST REVEALED A FAILURE TO DELIVER HIGH VOLTAGE THERAPY. THE DEVICE WAS ABLE TO CHARGE BUT WOULD NOT DELIVER. THE CAUSE WAS IDENTIFIED AS CATASTROPHIC DAMAGE TO AN INTEGRATED CIRCUIT. IT WAS NOT POSSIBLE TO DETERMINE IF THE DAMAGE OCCURRED IN THE FIELD OR HAPPENED AFTER THE EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD HAD AN INSULATION BREACH. THE LEAD WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD HAD AN INSULATION BREACH. THE LEAD WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IN ADDITION, THE DEVICE WAS RETURNED, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB