BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 4210534 · Received October 29, 2014

    Report

    Report Number
    2134265-2014-06577
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPN: CORRECTED FROM UNK372 TO M001262210. CATALOG/MODEL #: CORRECTED FROM UNKNOWN TO 26-221. DEVICE LOT NUMBER: CORRECTED FROM UNKNOWN TO 062906-001. DEVICE EXPIRATION DATE: CORRECTED FROM UNKNOWN TO 07/31/2016. DEVICE MANUFACTURED DATE: CORRECTED FROM UNKNOWN TO 08/03/2006. (B)(4).

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED PAD BURNS. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) OF THE KIDNEY WITH A RF3000 RADIOFREQUENCY GENERATOR. TREATMENT TIME WAS 43-44 MINUTES IN LENGTH. UPON COMPLETION OF THE PROCEDURE, BURNS TO THE SKIN AT THE SITE OF THE GROUNDING PADS WERE OBSERVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED PAD BURNS. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) OF THE KIDNEY WITH A RF3000 RADIOFREQUENCY GENERATOR. TREATMENT TIME WAS 43-44 MINUTES IN LENGTH. UPON COMPLETION OF THE PROCEDURE, BURNS TO THE SKIN AT THE SITE OF THE GROUNDING PADS WERE OBSERVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691372 RF3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SAN JOSE M001262210 062906-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GROUNDING PADS (4): TYCO HEALTHCARE/COVIDIEN