BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1648017 · Received April 1, 2010

    Report

    Report Number
    2649622-2010-01700
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    February 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) UPON FURTHER REVIEW OF LEAD ANALYSIS FINDING, THE LEAD TESTED WITHIN SPECIFICATION WITH NO ANOMALIES FOUND. IT HAD PREVIOUSLY BEEN REPORTED - TIP SEAL PROBLEM. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - HELIX WILL NOT EXTEND AT THIS TIME DUE TO DRIED BLOOD IN THE TIP END OF THE DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE IS-1 PIN IS ROTATED.

    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) UPON FURTHER REVIEW OF LEAD ANALYSIS FINDING, THE LEAD TESTED WITHIN SPECIFICATION WITH NO ANOMALIES FOUND. IT HAD PREVIOUSLY BEEN REPORTED - TIP SEAL PROBLEM. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - HELIX WILL NOT EXTEND AT THIS TIME DUE TO DRIED BLOOD IN THE TIP END OF THE DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE IS-1 PIN IS ROTATED. (B)(4) UPON FURTHER REVIEW OF LEAD ANALYSIS FINDING, THE LEAD TESTED WITHIN SPECIFICATION WITH NO ANOMALIES FOUND. IT HAD PREVIOUSLY BEEN REPORTED - TIP SEAL PROBLEM. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - HELIX WILL NOT EXTEND AT THIS TIME DUE TO DRIED BLOOD IN THE TIP END OF THE DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE IS-1 PIN IS ROTATED. (B)(4) ANALYSIS OF THIS DEVICE COULD NOT BE CONDUCTED AT THIS TIME BECAUSE THE DEVICE COULD NOT BE LOCATED. IF LOCATED, ANALYSIS WILL BE COMPLETED AND THE RESULTS WILL BE FORWARDED.

    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) TIP SEAL PROBLEM. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - HELIX WILL NOT EXTEND AT THIS TIME DUE TO DRIED BLOOD IN THE TIP END OF THE DISTAL CONDUCTOR PREVENTING TORQUE TRANSFER WHEN THE IS-1 PIN IS ROTATED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING A DEVICE UPGRADE AND NEW LEADS IMPLANTED ON (B) (6) 2010 WHEN HE DIED DURING SURGERY. FOLLOW UP REVEALED THERE IS NO ALLEGATION THAT THE DEATH WAS DEVICE RELATED, "MORE PROCEDURE RELATED." LATER FOLLOW UP REPORTED THE PATIENT DIED OF CORONARY ARTERY DISEASE AND REFRACTORY VENTRICULAR TACHYCARDIA ARREST PER THE PHYSICIAN WITH NO ALLEGATION OF DEVICE SYSTEM ISSUE. "PATIENT ESSENTIALLY HAD VT STORM AND DIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE ASKU LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| LEAD/STJ IMPLANTABLE PACING LEAD| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB