BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6340048 · Received February 17, 2017

    Report

    Report Number
    3007566237-2017-00712
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    May 2, 2016
    Report Date
    September 19, 2024
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. CODING HAS BEEN UPDATED TO CURRENT STANDARD. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    MFG. SITE ID WAS UPDATED (B)(4). ADDITIONAL REVIEW DETERMINED THE FOLLOWING PATIENT CODE WAS NOT RELATED TO THIS EVENT: (B)(4). THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389-28, LOT# 0208980778, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389-28, LOT# 0209392209, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

    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 · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PATIENT HAD AN ACCIDENTAL TRAUMA TO THEIR SCALP THAT RESULTED IN THE EXPOSURE OF THE DEEP BRAIN STIMULATION (DBS). A REVISION WAS DONE AND BOTH EXTENSION CABLES AND LEFT LEAD WAS EXPLANTED ON (B)(6) 2017. THE RIGHT LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) REMAINED IMPLANTED. TO AVOID OPENING THE INS SITE, TO MINIMIZE THE RISK OF INFECTION SPREADING TO THE INS, THE HCP CUT THE EXTENSIONS IN THE SCALP AND REMOVED THE PROXIMAL ENDS. THE DISTAL ENDS OF THE EXTENSIONS WERE STILL IMPLANTED AND CONNECTED TO THE INS. DUE TO FINANCIAL CONSTRAINTS THE PATIENT WANTED TO RE-USE THE INS FOLLOWING RE-IMPLANT OF THE LEFT LEAD AND EXTENSIONS. THERE WAS NO CLINICAL EVIDENCE OF ANY INFECTION AT THE TIME OF THIS REPORT, BUT THE PATIENT WAS CAUTIONED ON THE RISKS OF RETAINING PART OF THE INFECTED HARDWARE. THE INS WAS SWITCHED OFF AND THE VOLTAGE WAS SET TO 0V ON BOTH SIDES. RE-IMPLANT WAS GOING TO BE DONE ONLY AFTER A SAFE INTERVAL OF SIX MONTHS TO ENSURE NO TRACE OF INFECTION IS PERSISTING. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DUAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED THE PATIENT UNDERWENT A PARTIAL EXPLANT FOLLOWING INFECTION OF THEIR DEEP BRAIN STIMULATION (DBS) HARDWARE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 FOR WOUND DEHISCENCE AT THE LEFT BURR HOLE SITE RESULTING IN EXPOSURE OF THE DBS HARDWARE. IT WAS UNKNOWN IF THE WOUND WAS FROM LOCAL TRAUMA. THE PATIENT UNDERWENT SECOND SUTURING OF THE WOUND AFTER FRESHENING THE EDGES. BACTERIOLOGICAL CULTURE FROM THE SITE AS WELL AS TISSUE BITS TAKEN FROM THE WOUND EDGE SHOWED NO GROWTH. THE PATIENT WAS ADMITTED TO THE HOSPITAL AGAIN ON (B)(6) 2016 FOR MANAGEMENT OF THE WOUND DEHISCENCE FOLLOWING SUTURE REMOVAL. THE PATIENT UNDERWENT SECOND SUTURING AFTER TAKING A SKIN FLAP TO COVER THE WOUND. BACTERIOLOGICAL CULTURE OF TISSUE BITS FROM THE WOUND EDGE SHOWED NO GROWTH. THE PATIENT WAS DISCHARGED AFTER ONE WEEK. ON (B)(6) 2016, THE PATIENT WAS ADMITTED TO THE HOSPITAL AGAIN FOR PURULENT DISCHARGE FROM THE WOUND SITE. CULTURE OF THE DISCHARGE GREW KLEBSIELLA PNEUMONIAE. A WOUND RE-EXPLORATION SURGERY WAS DONE AND THE DBS CONNECTING WIRE WAS REPOSITIONED, GRANULATION TISSUE WAS REMOVED, AND THE SKIN FLAP WAS RE-SUTURED. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL AGAIN WITH RECURRENT INFECTION AT THE IMPLANT SITE. CULTURE GREW KLEBSIELLA PNEUMONIAE. A REVISION WAS DONE TO EXPLANT THE LEFT LEAD AND BOTH EX TENSIONS. THE PATIENT WAS DISCHARGED ON (B)(6) 2017 AND THEY WERE CURRENTLY ON ORAL ANTIBIOTICS. WOUND INSPECTION ON (B)(6) 2017 SHOWED NO CLINICAL EVIDENCE OF ANY ACTIVE INFECTION. THE PLAN FOR THE PATIENT WAS TO RE-IMPLANT THE LEFT LEAD AND BOTH WIRES AND THEN START STIMULATION AFTER ENSURING THERE IS NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122834 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC EUROPE SARL 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R "SEE H10...."