BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1737580 · Received June 28, 2010

    Report

    Report Number
    2649622-2010-06847
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    May 6, 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. EVALUATION SUMMARY (B) (4) BATTERY DEPLETION-NORMAL. NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION MELTED, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED. (B) (4) PROXIMAL CONDUCTOR FRACTURED, DISTAL CONDUCTOR FRACTURED, DEFIB CONDUCTOR FRACTURED, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), DISTAL CONDUCTOR FRACTURE (OVERSTRESS), BLOOD/BODY FLUID OUTER TUBING OVERLAY, INNER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY MELTED, OUTER TUBING SEPARATION (NON-ELECTRICAL), BLOOD IN/ON HELIX/LOBE MECHANISM, DEFORMATION/FRACTURE IN 5 CM PROXIMAL SECTION OF THE INNER COIL - EXTENSION PROBLEMS. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    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 AND LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT HAD BEEN REPORTED THE RV (RIGHT VENTRICULAR) LEAD IMPEDANCE HAD INCREASED TO GREATER THAN 1500 OHMS, THERE WAS NOISE, OVERSENSING, FRACTURE, AND INAPPROPRIATE SHOCKS. THE PATIENT'S WIFE LATER REPORTED THAT ON (B) (6)2010, THE PATIENT WAS TAKEN TO THE HOSPITAL AFTER RECEIVING SEVERAL SHOCKS AND HAD SURGERY TO "REPLACE THE WIRE, BUT DIED TWO DAYS LATER." SHE ALSO REPORTED THE DEATH CERTIFICATE LISTED CAUSE OF DEATH AS "CARDIAC GENETIC SHOCK, SEPTICEMIA OR SOMETHING." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. CAUSE OF DEATH HAS BEEN REQUESTED OF THE PHYSICIAN AND NOT RECEIVED. FURTHER REPORTED "THE LEAD WAS VERY LIKELY FRACTURED AND PLANS WERE TO REPLACE IT."

    Description of Event or Problem · 1

    IT HAD BEEN REPORTED THE RV (RIGHT VENTRICULAR) LEAD IMPEDANCE HAD INCREASED TO GREATER THAN 1500 OHMS, THERE WAS NOISE, OVERSENSING, FRACTURE, AND INAPPROPRIATE SHOCKS. THE PATIENT'S WIFE LATER REPORTED THAT ON (B)(6) 2010, THE PATIENT WAS TAKEN TO THE HOSPITAL AFTER RECEIVING SEVERAL SHOCKS AND HAD SURGERY TO "REPLACE THE WIRE, BUT DIED TWO DAYS LATER." SHE ALSO REPORTED THE DEATH CERTIFICATE LISTED CAUSE OF DEATH AS "CARDIAC GENETIC SHOCK, SEPTICEMIA OR SOMETHING." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. CAUSE OF DEATH HAS BEEN REQUESTED OF THE PHYSICIAN AND NOT RECEIVED.

    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 78 YR Death 4196 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB