BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 11569932 · Received March 25, 2021

    Report

    Report Number
    2182207-2021-00521
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    December 21, 2020
    Report Date
    May 7, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5: CORRECTION TO THE PREVIOUSLY REPORTED LEAD POSITIONING ISSUE. 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

    LEAD POSITIONING WAS INACCURATE IN 6 PATIENTS. 5 CASES OCCURRED IN PARKINSON'S AND 1 IN DYSTONIA. 5 CASES WERE ACCOMPANIED BY CONFUSION WHICH LED TO DIFFICULTY IN ACCURATE NEUROPHYSIOLOGICAL EXPLORATION. 3 CASES OF BRAIN SHIFT DUE TO PNEUMOCEPHALUS CONTRIBUTED TO THE ISSUE, AND IN ONE CASE THE CAUSE COULD NOT BE DETERMINED. 2 PATIENTS IMPLANTED IN THE SUBTHALAMIC NUCLEUS AND ONE PATIENT IMPLANTED FOR DYSTONIA AGREED TO REPOSITION THE LEADS TO RESOLVE THE ISSUE AND 3 WANTED TO MANAGE WITH PROGRAMMING.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. PROCODE, REPORT SOURCE: PLEASE NOTE THE PMA AND PRODUCT CODE FOR THE PATIENTS IMPLANT FOR DYSTONIA. MRU, H050007. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DOSHI PK, RAIN, DAS D. SURGICAL AND HARDWARE COMPLICATIONS OF DEEP BRAIN STIMULATION-A SINGLE SURGEON EXPERIENCE OF 519 CASES OVER 20 YEARS. NEUROMODULATION. 2021. 10.1111/NER.13360   A RETROSPECTIVE ANALYSIS OF 519 PATIENTS (1024 LEADS) WHO UNDERWENT DBS SURGERY AND 232 PATIENTS WHO UNDERWENT IMPLANTABLE PULSE GENERATOR REPLACEMENT (IPG), BY A SINGLE SURGEON, BETWEEN THE YEARS 1999 AND 2019 WAS PERFORMED. PERIOPERATIVE AND HARDWARE RELATED COMPLICATIONS WERE EVALUATED. REPORTED EVENTS: SURGERY WAS ABANDONED IN 1 PATIENT DUE TO ASPIRATION DURING THE SURGERY BECAUSE OF SEVERE CONFUSION. 7 PATIENTS EXPERIENCED INTRACEREBRAL HEMORRHAGE. SURGERY WAS ABANDONED IN 2 PATIENTS DUE TO HEMIPARESIS. A CT SCAN REVEALED A SMALL HEMATOMA ALONG THE MER TRACT. 1 PATIENT WAS LEFT WITH RESIDUAL HEMIPARESIS.  VASOVAGAL SYNCOPE WAS OBSERVED IN 3 PATIENTS. THIS MANIFESTED WITH A LOSS OF CONSCIOUSNESS AND A FALL IN BLOOD PRESSURE. ALL THE PATIENTS RECOVERED WITHIN A FEW MINUTES. RESPIRATORY DISTRESS OCCURRED IN 2 PATIENTS. SURGERY WAS POSTPONED FOR ONE OF THE PATIENTS. SEVER BLEPHAROSPASM WAS OBSERVED IN TWO PATIENTS AFTER SURGERY. THE PATIENTS REMAINED SLEEPY AND RECOVERED WITH PROGRAMMING.   LEAD POSITIONING WAS INACCURATE IN 6 PATIENTS. 5 CASES OCCURRED IN PARKINSON'S AND 1 IN DYSTONIA. 5 CASES WERE ACCOMPANIED BY CONFUSION WHICH LED TO DIFFICULTY IN ACCURATE NEUROPHYSIOLOGICAL EXPLORATION. 3 CASES OF BRAIN SHIFT DUE TO PNEUMOCEPHALUS CONTRIBUTED TO THE ISSUE, AND IN ONE CASE THE CAUSE COULD NOT BE DETERMINED. 2 PATIENTS AGREED TO REPOSITION THE LEADS AND 3 WANTED TO MANAGE WITH PROGRAMMING. 22 CASES OF INFECTION AND EROSION OF THE HARDWARE WAS OBSERVED. FULL SYSTEM EXPLANT WAS DONE IN 9 PATIENTS, PARTIAL EXPLANT WAS DONE IN 5 PATIENTS AND THE INS WAS EXPLANTED IN ANOTHER 5 PATIENTS. 2 PATIENTS WERE RE-IMPLANTED. INS MALFUNCTION WAS DIAGNOSED IN TWO PATIENTS AFTER THE DEVICE COULD NOT BE INTERROGATED. IN ONE THE CASES THE PATIENT RESET THE DEVICE THEMSELVES IN AN EFFORT TO PROGRAM THE DEVICE. THE OTHER CAUSE COULD NOT BE DETERMINED. THE INS WAS REPLACED IN BOTH OF THE PATIENTS.   EXTENSION FRACTURE WAS FOUND IN TWO PATIENTS AFTER HIGH IMPEDANCE WAS FOUND DURING PROGRAMMING. THE EXTENSIONS WERE REPLACED RESOLVING THE ISSUE. 3 PATIENTS EXPERIENCED HARDWARE DISCOMFORT MANIFESTED BY SWELLING AT THE INS SITE IN TWO PATIENTS. HEMATOMA WAS DISCOVERED IN ONE PATIENT. THE HEMATOMA WAS DRAINED AND THE BLEEDING POINT WAS SECURED AFTER EXPLORATION OF THE INS SITE. THE CAUSE WAS NOT DETERMINED IN THE SECOND PATIENT AND THE THIRD WAS FOUND TO BE DUE TO SKIN REACTION AND IRRITATION NEAR THE INS SITE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466644 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention