BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK DSP

    MDR report key: 3734213 · Received April 8, 2014

    Report

    Report Number
    2124215-2014-07755
    Event Type
    Death
    Date Received
    April 8, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV DEFIBRILLATION LEAD WAS RETURNED SEVERED (210 MM FROM THE TERMINAL PIN). ONLY THE PROXIMAL LEAD SEGMENT WAS RETURNED TO BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT. SET SCREW MARKS (INDICATIVE OF SETSCREW-LEAD TERMINAL CONTACT) WERE NOTED ON ALL OF THE TERMINALS. A CUT WAS OBSERVED IN THE LEAD YOKE AREA AND BODILY FLUID WAS NOTED IN THE LUMEN OF THE LEAD SEGMENT. THE PROXIMAL LEAD SEGMENT WAS PUT THROUGH AND PASSED ELECTRICAL CONTINUITY AND INNER INSULATION INTEGRITY TESTING. DETAILED ANALYSIS IDENTIFIED A LEAD INSULATION ABRASION (147-148MM FROM THE TERMINAL PIN) THROUGH TO THE PROXIMAL HIGH VOLTAGE LUMEN. THE INSULATION APPEARS TO BE INTACT. THE DAMAGED AREA WOULD NOT HAVE BEEN EXPOSED AS IT WOULD HAVE BEEN LOCATED WITHIN THE FOLD. THE PROXIMAL HIGH VOLTAGE CABLE INSULATION IS INTACT AND UNDAMAGED. IT SHOULD BE NOTED THAT THE PROXIMAL HIGH VOLTAGE CABLE IS NOT INVOLVED IN ANY TYPE OF SENSING, IT IS FOR SHOCKING PURPOSES ONLY. THE LEAD APPEARS TO HAVE BEEN TWISTED IN THIS AREA AND THE ABRASION IS LOCATED IN ONE OF THE FOLDS. ADDITIONALLY, THERE IS A SLIGHT WEBBING DAMAGE BETWEEN THE DISTAL AND PROXIMAL HIGH VOLTAGE LUMENS. THE INSULATION OF BOTH THE DISTAL AND PROXIMAL HIGH VOLTAGE LUMENS APPEARS TO BE INTACT AND UNDAMAGED. IT WAS CONCLUDED THAT THE INSULATION WAS INTACT AND WOULD HAVE PERFORMED NORMALLY DURING HIGH ENERGY THERAPY DELIVERY WHILE IMPLANTED. THE OBSERVED DAMAGE TO THIS LEAD APPEARS CONSISTENT WITH LEAD-ON-LEAD CONTACT.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A MEDICAL EXAMINER'S (ME) OFFICE IN (B)(6) 2014 THAT THIS PATIENT HAD DIED IN LATE-(B)(6) 2014. THE DEVICE HISTORY IS SIGNIFICANT FOR IMPLANT (REPLACEMENT PROCEDURE) OF A COMPETITOR DEVICE IN LATE-(B)(6) 2014. THE BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS RETURNED IN MID-(B)(6) 2014 AND THE ME WAS REQUESTING LABORATORY TESTING. THERE WERE NO ALLEGATIONS OF LEAD MALFUNCTION OR THAT THE USE OF THIS RV DEFIBRILLATION LEAD CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE ME'S OFFICE WAS CONTACTED VIA PHONE. ACCORDING TO THE FORENSIC PATHOLOGIST ASSISTANT, THE PATIENT HAD BEEN ADMITTED INTO THE HOSPITAL IN MID-(B)(6) 2014 DUE TO AN ICD INFECTION. THE PATIENT HAD BEEN ADMITTED A COUPLE OF DAYS EARLY TO MANAGE ANTICOAGULANT MEDICATION. THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY, THE COMPETITOR DEVICE AND BOSTON SCIENTIFIC RV LEAD WERE EXPLANTED WITHOUT INCIDENT. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. THE PATIENT'S CHEST WAS OPENED AND RV PERFORATION (TAMPONADE) WAS IDENTIFIED. DESPITE EMERGENCY MEASURES, THE PATIENT COULD NOT BE STABILIZED AND DIED. THE CAUSE OF DEATH WAS LISTED AS INTRATHORACIC HEMORRHAGE AS A RESULT OF AN RV PERFORATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A FORMER BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT THIS LEAD WILL BE EXPLANTED AND REPLACED. IT IS UNKNOWN AT THIS TIME WHY THE LEAD MAY BE EXPLANTED, OR EVEN IF IT HAS BEEN EXPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED AT THAT TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211309 ENDOTAK DSP IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0095

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H| L| R 0095| 1860| 1762