BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 826057 · Received March 9, 2007

    Report

    Report Number
    2649622-2007-00456
    Event Type
    Injury
    Date Received
    March 9, 2007
    Date of Event
    December 12, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY AND TESTED OUT OF SPECIFICATION CONSISTENT WITH THE ADVISORY. EVALUATION SUMMARY: PROXIMAL CONDUCTOR WAS FRACTURED; FULL LEAD WAS RETURNED FOR ANALYSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED 12 INAPPROPRIATE SHOCKS DUE TO RV LEAD FRACTURE. UNACCEPTABLE THRESHOLDS, OVERSENSING, AND HIGH VARYING LEAD IMPEDANCE (700-2150 OHMS) WERE ALSO OBSERVED. DURING LEAD EXPLANT THE STYLET WOULD NOT PASS THROUGH THE CONNECTOR DUE TO BLOOD INGRESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION FROM AN ATTORNEY ALLEGES THE PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, AND MENTAL ANGUISH AS A RESULT OF THE LEAD. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION LEAD CONDUCTOR COMPONENT/SUBASSEMBLY FAILURE (SELECT SPECIFIC CODE FROM CATEGORY D) DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT IMPEDANCE, HIGH LEAD(S), FRACTURE OF OVERSENSING SENSITIVITY SHOCK, INAPPROPRIATE BLOOD CONTAMINATED DEVICE HIGH THRESHOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED 12 INAPPROPRIATE SHOCKS DUE TO RV LEAD FRACTURE. UNACCEPTABLE THRESHOLDS, OVERSENSING, AND HIGH VARYING LEAD IMPEDANCE (700-2150 OHMS) WERE ALSO OBSERVED. DURING LEAD EXPLANT THE STYLET WOULD NOT PASS THROUGH THE CONNECTOR DUE TO BLOOD INGRESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED 12 INAPPROPRIATE SHOCKS DUE TO RV LEAD FRACTURE. UNACCEPTABLE THRESHOLDS, OVERSENSING, AND HIGH VARYING LEAD IMPEDANCE (700-2150 OHMS) WERE ALSO OBSERVED. DURING LEAD EXPLANT THE STYLET WOULD NOT PASS THROUGH THE CONNECTOR DUE TO BLOOD INGRESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION FROM AN ATTORNEY ALLEGES THE PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, AND MENTAL ANGUISH AS A RESULT OF THE LEAD.

    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 46 YR Required Intervention