BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1992677 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02986
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 14, 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
    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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. DETAILED ANALYSIS OF THE LEAD WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT BETWEEN (B)(6) 2010, THERE WAS AN ABRUPT INCREASE IN VENTRICULAR PACING IMPEDANCE. IT WAS ALSO REVEALED THAT THE SHORT INTERVAL COUNT INCREASED 17510 COUNTS. IN ADDITION, IT WAS REVEALED THAT THERE WAS A LEAD INTEGRITY ALERT ON (B)(6) 2010.

    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. DETAILED ANALYSIS OF THE LEAD WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD FRACTURE. AFTER EXPLANTING THE LEAD, BLOOD PRESSURE DROPPED DRAMATICALLY AND A LARGE PERICARDIAL EFFUSION WAS OBSERVED. CPR WAS INITIATED DURING PERICARDIAL ACCESS AS THE PATIENT BECAME PULSELESS AND WAS TRANSIENTLY ASYSTOLIC. THE PERICARDIAL SPACE WAS DRAINED OF DARK BLOOD, WHEREUPON SINUS RHYTHM RETURNED AND SYSTOLIC PRESSURE IMPROVED. DESPITE REMOVAL OF THE BLOOD A LARGE PERICARDIAL EFFUSION REMAINED EVIDENT ON FLUOROSCOPY. CPR WAS RESUMED UNTIL A SURGICAL TEAM PROCEEDED TO CREATE A PERICARDIAL WINDOW, AND MORE DARK BLOOD WAS REMOVED. CONTINUED MANIPULATION OF THE PERICARDIAL WINDOW WAS REQUIRED TO RELIEVE PRESSURE, WITH POSITIVE IMPROVEMENT IN HEMODYNAMICS EACH TIME. THE PATIENT WAS EVENTUALLY SENT FOR A STERNOTOMY TO REPAIR A PRESUMED CARDIAC LACERATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS A LEAD FRACTURE. AFTER EXPLANTING THE LEAD, BLOOD PRESSURE DROPPED DRAMATICALLY AND A LARGE PERICARDIAL EFFUSION WAS OBSERVED. CPR WAS INITIATED DURING PERICARDIAL ACCESS AS THE PATIENT BECAME PULSELESS AND WAS TRANSIENTLY ASYSTOLIC. THE PERICARDIAL SPACE WAS DRAINED OF DARK BLOOD, WHEREUPON SINUS RHYTHM RETURNED AND SYSTOLIC PRESSURE IMPROVED. DESPITE REMOVAL OF THE BLOOD A LARGE PERICARDIAL EFFUSION REMAINED EVIDENT ON FLUOROSCOPY. CPR WAS RESUMED UNTIL A SURGICAL TEAM PROCEEDED TO CREATE A PERICARDIAL WINDOW, AND MORE DARK BLOOD WAS REMOVED. CONTINUED MANIPULATION OF THE PERICARDIAL WINDOW WAS REQUIRED TO RELIEVE PRESSURE, WITH POSITIVE IMPROVEMENT IN HEMODYNAMICS EACH TIME. THE PATIENT WAS EVENTUALLY SENT FOR A STERNOTOMY TO REPAIR A PRESUMED CARDIAC LACERATION. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD