BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

    MDR report key: 4578648 · Received March 6, 2015

    Report

    Report Number
    2029046-2015-00052
    Event Type
    Injury
    Date Received
    March 6, 2015
    Date of Event
    June 1, 2014
    Report Date
    February 23, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. OTHER BWI PRODUCTS WERE USED DURING THIS PROCEDURE: STOCKERT CORDIS, CARTO OTHER COMPANY¿S DEVICES WERE USED IN THE ABOVE STUDY: INQUIRY, ST. JUDE MEDICAL. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE. FROM THE ARTICLE TWO PATIENTS UNDERWENT EPICARDIAL TRANSPERICARDIAL MAPPING AND HAD SYMPTOMS OF A STERILE PERICARDITIS AFTER THE PROCEDURE. THESE PATIENTS RECOVERED APPROXIMATELY 1 WEEK AFTER THE PROCEDURE. IT IS UNKNOWN IF THE PATIENTS REQUIRED MEDICAL OR SURGICAL INTERVENTION. SEVERAL ATTEMPTS HAVE BEEN MADE, HOWEVER NO INFORMATION IS AVAILABLE AT THIS TIME. BASED ON THE NARRATIVE, THERE WERE NO COMPLAINTS REPORTED RELATED TO CATHETER MALFUNCTION IMMEDIATELY AFTER THE PROCEDURE WHICH MIGHT SUGGEST THAT THE COMPLICATION WAS PROCEDURE RELATED AND NOT A MALFUNCTION OF BWI PRODUCT. THEREFORE WE ARE TAKING CONSERVATIVE APPROACH AND REPORTING THIS COMPLAINT. TITLE: INCIDENCE AND RELEVANCE OF NONREENTRANT MONOMORPHIC VENTRICULAR TACHYCARDIA IN PATIENTS WITH FREQUENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR INTERVENTIONS. OBJECTIVES: THE AIMS OF THIS STUDY WERE TO EVALUATE THE INCIDENCE AND RELEVANCE OF NONREENTRANT VT IN ICD RECIPIENTS AND TO DETERMINE THE RESPONSIVENESS OF NO REENTRANT VTS TO ICD INTERVENTIONS AND CATHETER ABLATION. THE PATIENTS UNDERWENT 195 MAPPING AND ABLATION PROCEDURES BETWEEN 2004 AND (B)(6) 2014 ON 142 CONSECUTIVE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENTS. FURTHER COMPLICATIONS RELATED TO THE ABLATION PROCEDURE DID NOT OCCUR. THERE ARE NO DEATH EVENTS AND DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE WAS 3.5- OR 4-MM TIPPED IRRIGATED ABLATION CATHETER (CORDIS WEBSTER OR BIOSENSE WEBSTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159940 SIMILAR DEVICE NS7TCBL174HS, PMA # P990025 LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-00 UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening