BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1875123 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11632
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 17, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY MELTED AND BREACHED CUT, THE HELIX WAS DISTORTED/BENT, AND THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM.

    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY MELTED AND BREACHED CUT, THE HELIX WAS DISTORTED/BENT, AND THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    THE PATIENT REPORTED "I HAVE THE FAULTY LEAD, THE RECALLED ONE". IT WAS FURTHER REPORTED THAT THE PATIENT REQUESTED THAT HER (B)(4) FIDELIS LEAD BE REMOVED. DURING THE PROCEDURE, THE LEFT HEART LEAD ((B)(4)) AND THE RIGHT ATRIAL LEAD ((B)(4)) WERE FOUND TO BE "STUCK" TO THE FIDELIS LEAD AND HAD TO BE REMOVED AT THE SAME TIME. IT WAS ALSO REPORTED THAT THE IMPLANTED CRT-D DEVICE ((B)(4)) WAS REMOVED AND REPLACED BECAUSE OF SUSPECTED PREMATURE BATTERY DEPLETION. THE FIDELIS LEAD AND CRT-D DEVICE WERE RETURNED, THE TWO OTHER PACE/SENSE LEADS WERE NOT. ALL LEADS AND THE DEVICE WERE REPLACED. IT WAS ALSO REPORTED THAT MEDTRONIC RECEIVED INFORMATION THROUGH AN ATTORNEY THAT THE PATIENT WITH A SPRINT FIDELIS LEAD WAS A PARTICIPANT IN A LEGAL SETTLEMENT. MEDTRONIC RECEIVED INFORMATION THAT THIS LEAD HAD EXHIBITED A FRACTURE AND WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAVING "THE FAULTY LEAD, THE RECALLED ONE." IT WAS FURTHER REPORTED THAT THE PATIENT REQUESTED HER MODEL 6949 LEAD BE REMOVED. DURING THE PROCEDURE, THE MODEL 4193 CORONARY SINUS AND MODEL 5076 RIGHT ATRIAL LEADS WERE FOUND TO BE "STUCK" TO THE MODEL 6949 LEAD. ALL LEADS HAD TO BE REMOVED AND WERE REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB