BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT GROUNDING PAD

    MDR report key: 1081469 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01301
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE DEVICE MFR DATE IS UNK. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF FOUR INDIVIDUAL PT GROUNDING PADS. REFER TO MFR REPORT #S: 3005099803-2008-01299, 3005099803-2008-01300, AND 3005099803-2008-01302 FOR DETAILS REGARDING THE THREE ADDITIONAL GROUNDING PADS. REFER TO MFR REPORT #3005099803-2008-01298 FOR DETAILS REGARDING THE RF 3000 GENERATOR. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 6/27/08 THAT AN RF ABLATION PROCEDURE WAS PERFORMED ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE GENERATOR WAS NOT REGISTERING THAT THE PADS WERE OVERHEATING WHICH CAUSED BLISTERING/BURN ON THE PT." FOLLOW-UP INFO ASCERTAINED BY A BSC SALES REP CLARIFIED THE EVENT WITH THE FOLLOWING: THE PT BURN WAS NOTED AFTER THE RF ABLATION PROCEDURE; AND THE CONSOLE (GENERATOR) DID NOT DISPLAY ANY ERROR CODE. THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY BURN TREATMENT PROVIDED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT GROUNDING PAD GROUNDING PAD ODR BOSTON SCIENTIFIC CORPORATION M001262191 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other