BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 16022800 · Received December 21, 2022

    Report

    Report Number
    2182208-2022-04105
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    January 1, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/65 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: AN ANTIBIOTIC ENVELOPE TO REDUCE INFECTIONS IN DEEP BRAIN STIMULATION SURGERY. JOURNAL OF CLINICAL NEUROSCIENCE. 2022: S0967-5868(22)00442-8. DOI: 10.1016/J.JOCN.2022.10.031. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS ANTIBACTERIAL ABSORBABLE ENVELOPE. THE ARTICLE REPORTS TWO PATIENTS WITH SURGICAL SITE INFECTIONS (SSI) WITH THE IMPLANT OF A DEEP BRAIN STIMULATION (DBS) DEVICE AND THE USE OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE FIRST WAS A SUPERFICIAL-INCISIONAL INFECTION IN A PATIENT WITH KNOWN RETRO-AURICULAR ABSCESS THAT EXTENDED TOWARDS THE DEVICE SITE WITH INTRAOPERATIVE CULTURES GROWING METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA). THEY UNDERWENT A TRANSPOSITION OF THE UNDERLYING CRANIAL LEADS AND INSERTION OF A NEW DBS DEVICE TO THE CONTRALATERAL SIDE AND THEN PRESENTED WITH A UNILATERAL, LOCALIZED SWELLING OF A SCALP WOUND WHICH RESOLVED WITH A COURSE OF ANTIBIOTICS. THE OTHER PATIENT HAD A DEEP-INCISIONAL INFECTION. THE PATIENT HAD INADVERTENTLY SCRATCHED THEIR SCALP AND NECK WOUNDS APPROXIMATELY SIX MONTHS POST-OPERATIVELY, WHICH RESULTED IN THE DEVELOPMENT OF AN SSI AND EXTRUSION OF THE UNDERLYING LEADS. THIS REQUIRED REVISION OF BOTH THE SCALP AND NECK WOUNDS AND INTRAOPERATIVE CULTURES GREW ENTEROBACTER AEROGENES. THE DBS DEVICE AND LEADS APPEAR TO BE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024744 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL MEDTRONIC, INC. TYRX-AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R