BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1500T11 RF ABLATION GENERATOR

    MDR report key: 2103647 · Received May 20, 2011

    Report

    Report Number
    2030404-2011-00117
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING AN ATRIAL TACHYCARDIA SLOW PATHWAY ABLATION PROCEDURE WITH A NON SJM CATHETER AND AN IBI GENERATOR, A STEAMPOP OCCURRED AT THE ATRIAL TACHYCARDIA ORIGIN (CORONARY SINUS OSTIUM). FOLLOWING THE STEAMPOP, IT WAS NOTED THAT THE PT'S RHYTHM TEMPORARILY WENT INTO A 2:1 AV BLOCK. THE PT WENT TO THE RECOVERY ROOM IN NORMAL SINUS RHYTHM BUT LATER THAT AFTERNOON HAD ALTERNATING EPISODES OF 2:1 AV BLOCK AND NORMAL SINUS RHYTHM. THE PT COMPLAINTS OF DIZZINESS WHEN HAVING 2:1 AV BLOCK BUT IS NOTED TO HAVE HAD THE SAME SYMPTOMS BEFORE THE ABLATION PROCEDURE SO THE AV BLOCK MAY HAVE EXISTED PRIOR TO PERFORMING THE ABLATION BUT THIS WAS NOT DOCUMENTED. THE PT REMAINS HOSPITALIZED BUT STABLE AND THERE HAS NOT BEEN A DECISION MADE AS TO WHETHER THE PT WILL REQUIRE IMPLANTATION OF A PERMANENT PACEMAKER. THE SETTINGS ON THE GENERATOR WERE AS FOLLOWS: TIME 40 SECONDS, AVERAGE TEMPERATURE 49 DEGREES CELSIUS, AVERAGE IMPEDANCE 83, AVERAGE VOLT 56, AVERAGE POWER 40 WATTS, AVERAGE CURRENT 690, MAXIMUM TEMPERATURE 54 DEGREES CELSIUS, MAXIMUM IMPEDANCE 105, MAXIMUM VOLTAGE 56, MAXIMUM POWER 46, MAXIMUM CURRENT 772.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1500T11 RF ABLATION GENERATOR GENERATOR, LESION, RADIOFREQUENCY OAD ST. JUDE MEDICAL, IRVINE 85523 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other BIOSENSE CATHETER