BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZY PACING LEAD

    MDR report key: 3009180 · Received March 12, 2013

    Report

    Report Number
    1035166-2013-00004
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DEATH WAS DOCUMENTED AS MYOCARDIAL INFARCTION (MI). THE LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. THERE WERE NO MFG REJECTS OR ANOMALIES RECORDED IN THE DEVICE HISTORY RECORD; THE LEAD PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER. ALSO, THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED, AND NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE CUSTOMER REPORTED THEY RECEIVED FROM AN OUT-OF-SERVICE FORM THAT THIS PT HAD BEEN PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULED SYSTEM EXTRACTION DUE TO INFECTION. THE SYSTEM WAS SUCCESSFULLY EXPLANTED WITH NO ADVERSE EVENTS REPORTED. SUBSEQUENTLY, THE CUSTOMER RECEIVED INFO THAT THIS PT DIED FOLLOWING THE PROCEDURE WHILE IN THE HOSP'S INTENSIVE CARE UNIT (ICU). ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT DEVICE-RELATED. ON (B)(6) 2013, AN UPDATED REPORT WAS RECEIVED FROM THE CUSTOMER; THEY RECEIVED INFO FROM AN OUT-OF-SERVICE FORM THAT THIS PT HAD BEEN PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR SCHEDULED SYSTEM EXTRACTION DUE TO INFECTION. THE CUSTOMER RECEIVED INFO THAT THIS PT DIED FOLLOWING THE PROCEDURE WHILE IN THE HOSP'S INTENSIVE CARE UNIT (ICU). ACCORDING TO THE PHYSICIAN, THE INFECTION WAS NOT DEVICE-RELATED, HOWEVER, THE EXTRACTION OF THE LEADS MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THE CAUSE OF DEATH WAS DOCUMENTED AS MYOCARDIAL INFARCTION (MI). SUBSEQUENTLY, THE CUSTOMER RECEIVED INFO THAT THE LOCAL REP SPOKE DIRECTLY WITH THE PHYSICIAN. A REVIEW OF THE OPERATIVE REPORT NOTED THAT DURING POCKET CLOSURE, THE PT DEVELOPED INFERIOR ST ELEVATIONS AND SUPERIOR/ANTERIOR/LATERAL ST DEPRESSION ASSOCIATED WITH A DROP IN BLOOD PRESSURE. HEMODYNAMIC STABILIZATION WAS ACHIEVED FOLLOWING ADMINISTRATION OF NORMAL SALINE SOLUTION (NSS) AND NEO-SYNEPHRINE. THE BLOOD PRESSURE STABILIZED BUT AFTER 2-3 MINUTES, LOW BLOOD PRESSURE WAS AGAIN ENCOUNTERED. THE PT WAS STARTED ON EPINEPHRINE, DOPAMINE, LEVOPHED AND DOBUTREX. THE PT WAS INTUBATED AND FEMORAL VENOUS/ARTERIAL ACCESS WAS OBTAINED. A TEMPORARY PACING WIRE WAS INSERTED. THE PT WAS STABILIZED AND TRANSFERRED TO THE ICU. UNFORTUNATELY, THE PT DIED SHORTLY UPON ARRIVAL TO THE ICU. THE ROOT CAUSE OF THE INFECTION REMAINS UNCERTAIN BUT THE PHYSICIAN SUSPECTS THAT THE INFECTION OCCURRED SOMETIME AFTER THE PACEMAKER REPLACEMENT IN (B)(6) 2010. THERE WAS NO IDENTIFIED VEGETATION ON THE IMPLANTED LEADS. BLOOD CULTURES WERE OBTAINED FROM THE POCKET SITE, HOWEVER, THE RESULTS ARE UNK AT THIS TIME. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 10 YEARS, 10 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104524 ZY PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. ZY 52 PJUSBV 2S12

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death