BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1670591 · Received April 30, 2010

    Report

    Report Number
    2649622-2010-01909
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    February 28, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) PROXIMAL CONDUCTOR FRACTURED, DEFIB CONDUCTOR FRACTURED, DISTAL CONDUCTOR DISTORTED, DEFIB CONDUCTOR DISTORTED, DEFIB CONDUCTOR CUT, PROXIMAL CONDUCTOR CUT, OUTER TUBING KINKED/BUCKLED, OUTER TUBING SEPARATION (NON-ELECTRICAL), OUTER INSULATION TORN, OUTER INSULATION BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM, LEAD STRETCHED. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - THE LEAD WAS RETURNED WITH THE PROXIMAL, RV, AND SVC CABLES CUT, EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) DEFIB CONDUCTOR FRACTURED. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - THE LEAD WAS RETURNED WITH THE PROXIMAL, RV, AND SVC CABLES CUT, EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) DEFIB CONDUCTOR FRACTURED. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - THE LEAD WAS RETURNED WITH THE PROXIMAL, RV, AND SVC CABLES CUT, EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN CLEARED BY HER CARDIOLOGIST TO HAVE COSMETIC SURGERY. SHE WAS UNDER ANESTHESIA FOR 6 HOURS FOR THE BREAST AUGMENTATION AND TUMMY TUCK AND DISCHARGED TO HOME. HER HUSBAND FOUND HER DEAD AT HOME THE NEXT DAY. THE LEAD WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED AN AUTOPSY WAS DONE WHICH NOTED THE CAUSE OF DEATH TO BE ACUTE COMBINED DRUG INTOXICATION WITH OTHER SIGNIFICANT FINDING OF HYPERTENSIVE CARDIOVASCULAR DISEASE.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. IT HAD BEEN REPORTED THE PATIENT HAD BEEN CLEARED BY HER CARDIOLOGIST TO HAVE COSMETIC SURGERY. SHE WAS UNDER ANESTHESIA FOR 6 HOURS FOR THE BREAST AUGMENTATION AND TUMMY TUCK AND DISCHARGED TO HOME. HER HUSBAND FOUND HER DEAD AT HOME THE NEXT DAY. THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN CLEARED BY HER CARDIOLOGIST TO HAVE COSMETIC SURGERY. SHE WAS UNDER ANESTHESIA FOR 6 HOURS FOR THE BREAST AUGMENTATION AND TUMMY TUCK AND DISCHARGED TO HOME. HER HUSBAND FOUND HER DEAD AT HOME THE NEXT DAY. THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED 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 48 YR Death (B) (4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD