BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 1841907 · Received September 23, 2010

    Report

    Report Number
    2649622-2010-09030
    Event Type
    Death
    Date Received
    September 23, 2010
    Date of Event
    June 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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) OUTER INSULATION SEPARATION, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED). DISTAL SEGMENT RETURNED AND ANALYZED.

    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) OUTER INSULATION SEPARATION, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), DISTAL CONDUCTOR FRACTURE(OVERSTRESS). DISTAL SEGMENT RETURNED AND ANALYZED.

    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) OUTER INSULATION SEPARATION, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), DISTAL CONDUCTOR FRACTURE(OVERSTRESS). DISTAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND (B)(4) OUTER INSULATION SEPARATION, PROXIMAL CONDUCTOR DISTORTED, DISTAL AND PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION TORN AND BREACHED CUT. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN FOUND DEAD IN BED BY HIS WIFE. AN AUTOPSY WAS PERFORMED THAT SHOWED CARDIOMEGALY AND ATHEROSCLEROTIC PLAQUE. HE HAD LAST BEEN SEEN BY HIS CARDIOLOGIST (B)(6) 2010 "WITHOUT SIGNIFICANT COMPLAINTS AT THAT TIME." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO MANUFACTURER FOLLOWING PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION RECEIVED REPORTED WIFE FOUND PATIENT DEAD IN BED. HE HAD LAST BEEN SEEN BY HIS CARDIOLOGIST (B)(6) 2010 "WITHOUT SIGNIFICANT COMPLAINTS AT THAT TIME," PHYSICIAN INDICATES PATIENT IN GOOD HEALTH, AND WAS ONLY PACING IN THE VENTRICLE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. AUTOPSY SHOWED CARDIOMEGALY AND ATHEROSCLEROTIC PLAQUE. FOLLOW UP REVEALED LAST DEVICE INTERROGATION ON (B)(6) 2009 SHOWED 4.5 YEARS REMAINING LONGEVITY. "THERE WERE TWO EPISODES OF HIGH VENTRICULAR RATE WITH IRREGULAR VENTRICULAR INTERVALS SUGGESTIVE OF ATRIAL FIBRILLATION, BUT VENTRICULAR TACHYCARDIA COULD NOT BE EXCLUDED." PATIENT EXPERIENCED VENTRICULAR HIGH RATE EPISODE OF OVER 8 MINUTES ON DAY OF DEATH. ALSO REPORTED DEVICE WENT TO ERI 2 DAYS AFTER PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death E2SR01 IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD