BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

    MDR report key: 1161624 · Received September 12, 2008

    Report

    Report Number
    2029046-2008-00029
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION REGARDING THIS EVENT INDICATES THAT EXTERNAL DEFIBRILLATION WAS REQUIRED IN ORDER TO RESTORE BASELINE VENTRICULAR PACED RHYTHM. THE PATIENT IS STABLE AND HAS BEEN DISCHARGED. THE EVENT DID NOT PROLONG HOSPITALIZATION OR DELAY DISCHARGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THIS CATHETER CURRENT LEAKED CAUSING A VENTRICULAR FIBRILLATION IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL LPB BIOSENSE WEBSTER, INC. D-1197-14-S 13056027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening STOCKERT RF GENERATOR| PRUCKA RECORDING SYSTEM| CARTO XP SYSTEM| BLOOM PACING STIMULATOR