BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 16172297 · Received January 15, 2023

    Report

    Report Number
    2182207-2023-00094
    Event Type
    Injury
    Date Received
    January 15, 2023
    Date of Event
    November 11, 2022
    Report Date
    January 15, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389-40, LOT# :UNKNOWN SERIAL#:, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: LEAD, PRODUCT ID: 3708660, LOT#: SE RIAL#: UNKNOWN, IMPLANTED:, EXPLANTED:, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389-40, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3708660, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: LIBEN ZHANG, S., LIM, J., HO, S., CHEONG, E., PING LEE, G., WAN, K., NG, W., PEK, C. SAVING THE EXPOSED DEEP BRAIN STIMULATION IMPLANT: A COMPREHENSIVE REVIEW OF IMPLANT EXTRUSION AND RECONSTRUCTIVE OPTIONS. ANNALS OF PLASTIC SURGERY. VOLUME 89, NUMBER 6. 2022. DOI: 10.1097/SAP.0000000000003318. AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. EVENT: IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. 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.

    Description of Event or Problem · 0

    LIBEN ZHANG, S., LIM, J., HO, S., CHEONG, E., PING LEE, G., WAN, K., NG, W., PEK, C. SAVING THE EXPOSED DEEP BRAIN STIMULATION IMPLANT: A COMPREHENSIVE REVIEW OF IMPLANT EXTRUSION AND RECONSTRUCTIVE OPTIONS. ANNALS OF PLASTIC SURGERY. VOLUME 89, NUMBER 6. 2022. DOI: 10.1097/SAP.0000000000003318. SUMMARY: INTRODUCTION: DEEP BRAIN STIMULATION (DBS) FOR THE TREATMENT OF PARKINSON DISEASE IS SUSCEPTIBLE TO COMPLICATIONS, SUCH AS HARDWARE EXTRUSION, MOST COMMONLY AT THE SCALP AND CHEST. THE AUTHORS DESCRIBE THEIR EXPERIENCE WITH THE MANAGEMENT OF HARDWARE EXTRUSION AND RECONSTRUCTION WITH ONE OF THE LARGEST SINGLE-INSTITUTION EXPERIENCE AND SUGGEST AN EVIDENCE-BASED TREATMENT ALGORITHM FOR THE MANAGEMENT OF SUCH CASES. METHODS: A RETROSPECTIVE REVIEW OF HOSPITAL RECORDS WAS PERFORMED TO IDENTIFY PATIENTS WHO UNDERWENT DBS-RELATED SURGERY AND RECONSTRUCTION FROM JANUARY 2015 TO APRIL 2020. MANAGEMENT OF THESE PATIENTS INVOLVED CULTURE-DIRECTED ANTIBIOTICS, LOCAL WOUND DEBRIDEMENT, VARIOUS FORMS OF RECONSTRUCTION, AND HARDWARE REMOVAL WHEN INDICATED. RESULTS: NINETY-FOUR PATIENTS WITH 131 DBS-RELATED PROCEDURES WERE INCLUDED. TWELVE PATIENTS (12.8%) HAD HARDWARE EXTRUSION, OF WHICH 6 OCCURRED PRIMARILY AT THE SCALP AND 6 OCCURRED PRIMARILY AT THE CHEST. PRIMARY CLOSURE OF SCALP WOUNDS (ODDS RATIO, 0.05[0.004¿0.71], P = 0.035) WAS NEGATIVELY ASSOCIATED WITH TREATMENT SUCCESS. THE TYPE OF RECONSTRUCTION OF CHEST WOUNDS DID NOT AFFECT ITS SUCCESS ( P = 0.58); HOWEVER, NONE OF THEM INVOLVED A NEW SURGICAL BED, SUCH AS CONTRALATERAL OR HYPOCHONDRIAL PLACEMENT. CONCLUSIONS: HARDWARE EXTRUSION IS A SIGN IFICANT COMPLICATION OF DBS-RELATED SURGERY. MANAGEMENT OF EXTRUSION AT THE SCALP SHOULD INVOLVE THE USE OF TENSION FREE, WELL-VASCULARIZED LOCOREGIONAL FLAPS AS OPPOSED TO PRIMARY CLOSURE. IMPLANTABLE PULSE GENERATOR EXTRUSIONS AT THE CHEST CAN BE MANAGED WITH BOTH PRIMARY CLOSURE AND REPOSITIONING IN A NEW SURGICAL BED. EXTRUDED DBS IMPLANTS MAY BE SALVAGED WITH APPROPRIATE RECONSTRUCTIVE CO NSIDERATIONS, AND THE AUTHORS SUGGEST AN EVIDENCE-BASED TREATMENT ALGORITHM. REPORTED EVENTS: 1. A 34 YEAR OLD MALE WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) IMPLANTATION DEVELOPED AN INFECTION (ABSCESS) AT THE POSTAURICULAR REGION OF THE WIRE 123 MONTHS (14 AFTER LAST BATTERY CHANGE) AFTER INITIAL IMPLANTATION. MSSA WAS FOUND AND THEY PERFORMED PRIMARY CLOSURE. THE OUTCOME WAS LOCAL RECURRENCE. THEY REPEATED PRIMARY CLOSURE AT 125 MONTHS. REMOVAL AND RESITING IN THE LEFT CHEST WAS PERFORMED AT 129 MONTHS. THE SALVAGE WAS SUCCESSFUL AT 129 MONTHS. "SEE ATTACHED LITERATURE ARTICLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655929 IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention