BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT RETURN GROUNDING PAD

    MDR report key: 1133206 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03610
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED. A DEVICE EVAL IS NOT AVAILABLE. THE RELATIONSHIP BETWEEN THE SUSPECT DEVICE, AND THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF FIVE DEVICES USED DURING THE SAME PROCEDURE. MFR REPORTS 3005099803-2008-03611, 3005099803-2008-03609, 3005099803-2008-03607 AND 3005099803-2008-03608 DESCRIBE THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008 THAT A PT RETURN GROUNDING PAD WAS USED DURING A RADIO FREQUENCY ABLATION PROCEDURE ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE PT RECEIVED A PAD BURN DURING THE PROCEDURE. THE BURN WAS APPROXIMATELY THREE INCHES (DIAMETER), HOWEVER, THE DEGREE OF THE BURN IS UNK. MULTIPLE ATTEMPTS HAVE BEEN MADE TO ASCERTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other