BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYHESIVE PATIENT RETURN ELECTRODE

    MDR report key: 1936018 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05259
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K822572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05258 AND 3005099803-2010-05260 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND TWO PATIENT RETURN GROUNDING PADS WERE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GENERATOR PAD ERROR (P1) OCCURRED. A SINGLE PAD WAS REPLACED, THEN THE ERROR (P1) RECURRED. AFTER THE SECOND ERROR (P1), THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE PATIENT RETURN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262191

    Patients

    Seq Age Sex Outcome Treatment
    1