BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN MANAGEMENT RADIOFREQUENCY PRODUCTS

    MDR report key: 6773358 · Received August 8, 2017

    Report

    Report Number
    3011270181-2017-00004
    Event Type
    Injury
    Date Received
    August 8, 2017
    Date of Event
    June 20, 2017
    Report Date
    September 6, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    GXD
    PMA / PMN Number
    K072478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 15AUG2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 02OCT2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 31JUL2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    A CONMED GROUNDING PAD WAS USED. A STANDARD NITINOL PROBE WAS USED AND A CABLE WAS IDENTIFIED AS HALYARD CODE PMX-BAY-MRF.  IT WAS REPORTED THAT A PATIENT CAME IN FOR A RECHECK AFTER HAVING AN RF LUMBAR PROCEDURE AND WAS FOUND TO HAVE A NECROTIC AND INFECTED BURN THAT WAS NOTICED (B)(6) 2017. IT WAS ORIGINALLY REPORTED THAT A BOSTON SCIENTIFIC'S GROUNDING PAD WAS USED DURING THE PROCEDURE. REFER TO (B)(4) FOR THE CABLE. REFER TO (B)(4) FOR THE PROBE . NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED 06-SEP-2017 THAT STATES THIS MFR # 3011270181-2017-00004 IS A DUPLICATE REPORT OF MFR # 3011270181-2017-00003. PLEASE SEE MFR # 3011270181-2017-00003 FOR ALL FURTHER REPORTING ON THIS EVENT. NO FURTHER INFORMATION WILL BE PROVIDED FOR 3011270181-2017-00004.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME IN FOR A RECHECK AFTER HAVING AN RF LUMBAR PROCEDURE AND WAS FOUND TO HAVE A NECROTIC AND INFECTED BURN THAT WAS NOTICED (B)(6) 2017. THE FACILITY USES BOSTON SCIENTIFIC'S GROUNDING PAD AND REPORTED PMG AND HAD SEVERAL HIGH IMPEDANCE WARNINGS DURING THE PROCEDURE; HOWEVER, THE STAFF OVER-RODE THE WARNING AND CONTINUED WITH THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554599 PAIN MANAGEMENT RADIOFREQUENCY PRODUCTS PAIN MANAGEMENT GENERATORS & ACCESSORIES GXD HALYARD HEALTH PMG-115 ST2137-005

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other BOSTON SCIENTIFIC GROUNDING PAD