BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 1675559 · Received May 6, 2010

    Report

    Report Number
    2649622-2010-01919
    Event Type
    Death
    Date Received
    May 6, 2010
    Date of Event
    February 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    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) FURTHER ANALYSIS OF THIS DEVICE WAS DONE. THOSE RESULTS ARE REFLECTED IN THIS SUPPLEMENTAL REPORT. ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. ADDITIONAL ANALYST COMMENT - ANALYSIS OF THE MEMORY DUMP DATA REVEALED THE DEVICE LEAD IMPEDANCES MEASURED OPEN ON (B) (6) 2010 WHICH IS THE SAME AS THE EXPLANT DATE OF (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. EVALUATION SUMMARY (B) (4) PRELIMINARY TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ADDITIONAL ANALYST COMMENT - ANALYSIS OF THE MEMORY DUMP DATA REVEALED THE DEVICE LEAD IMPEDANCES MEASURED OPEN ON (B) (4) 2010 WHICH IS THE SAME AS THE EXPLANT DATE OF (B) (6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COMPLETE SYSTEM REMOVAL PROCEDURE DUE TO AN INFECTION AND EROSION, PER THE OP REPORT, THE LAST 2CM OF THE LEAD WAS VERY FIBROTIC AND REQUIRED THE USE OF A 16 FRENCH LASER SHEATH. THE MOST DISTAL 1 CM OF THE LEAD REMAINED AS REMNANT. LATER REVIEW OF MANUFACTURING DATABASE REVEALED THE PATIENT DIED FIVE DAYS AFTER THIS PROCEDURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH IS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE CLINIC REVEALED THEY HAD SEEN THE PATIENT ON (B) (6) 2010 PRIOR TO THE EXPLANT, "AND EVERYTHING LOOKED GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE OPERATIVE REPORT THAT DURING COMPLETE SYSTEM REMOVAL PROCEDURE DUE TO AN INFECTION AND EROSION, THE LAST 2 CM OF THE RV (RIGHT VENTRICULAR) LEAD WAS VERY FIBROTIC AND REQUIRED THE USE OF A 16 FRENCH LASER SHEATH. THE MOST DISTAL 1 CM OF THE LEAD REMAINED IN THE PATIENT AS A REMNANT, WHILE THE REMAINDER OF THE LEAD WAS SUCCESSFULLY REMOVED. LATER REVIEW OF MANUFACTURING DATABASE REVEALED THE PATIENT DIED FIVE DAYS AFTER THIS PROCEDURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH IS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death