BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEPT

    MDR report key: 19106295 · Received April 15, 2024

    Report

    Report Number
    2182207-2024-02304
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 15, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME; PRODUCT ID: NEU_UNKNOWN_EXT; PRODUCT TYPE: 0191-EXTENSION; G2: CITATION: AUTHORS: PERMANA G. I., MORISHITA T., TANAKA H., MATSUSHITA R., KOBAYASHI H., ABE H.. ASYMPTOMATIC CABLE TWISTING IN A PATIENT WITH IMPENDING TWIDDLER SYNDROME DETECTED DURING DEEP BRAIN STIMULATION SURGERY FOR PARKINSON¿S DISEASE: A CASE REPORT. SURGICAL NEUROLOGY INTERNATIONAL 15(86) 2024. DOI: 10.25259/SNI_844_2023 · B.3. 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. B.5. 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. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. E: THE CORRESPONDING AUTHOR WAS LOCATED IN JAPAN. THE PRIMARY AUTHOR WAS LOCATED IN INDONESIA. THE CORRESPONDING AUTHORS INFORMATION WAS ADDED TO SECTION E AND THE FILE WAS LABELED AS INDONESIA. 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.

    Description of Event or Problem · 0

    PERMANA G. I., MORISHITA T., TANAKA H., MATSUSHITA R., KOBAYASHI H., ABE H. ASYMPTOMATIC CABLE TWISTING IN A PATIENT WITH IMPENDING TWIDDLER SYNDROME DETECTED DURING DEEP BRAIN STIMULATION SURGERY FOR PARKINSON¿S DISEASE: A CASE REPORT SURGICAL NEUROLOGY INTERNATIONAL 15(86) 2024 DOI: 10.25259/SNI_844_2023 ABSTRACT BACKGROUND: DEEP BRAIN STIMULATION (DBS) HAS CONSISTENTLY DEMONSTRATED HIGH EFFICACY AND SAFETY IN PATIENTS WITH PARKINSON¿S DISEASE. TWIDDLER¿S SYNDROME IS A RARE OCCURRENCE OF HARDWARE FAILURE IN PATIENTS UNDERGOING NEUROMODULATION. WE REPORT HERE A CASE OF SUBCLINICAL CABLE TWISTING JEOPARDIZING TWIDDLER¿S SYNDROME IN A PATIENT WITH PARKINSON¿S DISEASE WHO UNDERWENT DBS SURGERY TARGETING THE GLOBUS PALLIDUS INTERNUS (GPI). CASE DESCRIPTION: A 70-YEAR-OLD WOMAN WITH A 7-YEAR HISTORY OF PARKINSON¿S DISEASE REFRACTORY TO MEDICATION WAS REFERRED TO OUR DEPARTMENT FOR TREATMENT OF INVOLUNTARY MOVEMENTS OF THE LEFT HAND AND LEG. SHE UNDERWENT RIGHT GPI DBS IMPLANTATION. LEFT GPI DBS IMPLANTATION WAS SUBSEQUENTLY PLANNED TO MANAGE RESTING TREMORS THAT DEVELOPED IN THE RIGHT LEG AFTER THE FIRST SURGERY AT AROUND ONE YEAR AFTER THE FIRST SURGERY. DURING A ROUTINE CHECK-UP BEFORE THE SECOND SURGERY, WE INCIDENTALLY DETECTED TWIDDLER¿S SYNDROME. THE PATIENT SHOWED NO NEUROLOGICAL DEFICITS IN THE LEFT EXTREMITIES, THE SAME AS BEFORE RIGHT GPI DBS. WE PERFORMED LEFT GPI DBS CONCOMITANTLY WITH THE REVISION OF THE IMPLANTABLE PULSE GENERATOR AND EXTENSION WIRE. CONCLUSION: TWIDDLER¿S SYNDROME IS A RARE COMPLICATION OF DBS. SUBCLINICAL RISK OF CABLE TWISTING JEOPARDIZING TWIDDLER¿S SYNDROME IS RARELY DETECTED WITHOUT CLINICAL INDICATIONS OF HARDWARE FAILURE. NEUROSURGEONS SHOULD BE COGNIZANT OF AND REGULARLY MONITOR THE IMPLANTED DEVICE IN CASE SERIOUS COMPLICATIONS OCCUR. REPORTED EVENTS: 1) AROUND ONE YEAR AFTER DBS SURGERY, THE PATIENT DEVELOPED A RESTING TREMOR IN THE RIGHT LEG. A ROUTINE X-RAY SHOWED THE EXTENSION WIRE WAS TWISTED IN THE CHEST CAVITY, AND THE IPG WAS FLIPPED LEFT TO RIGHT. REVISION OF THE IPG AND EXTENSION WIRE WERE DONE. THE IPG WAS FIXED TO THE PECTORAL FASCIA BY SUTURES. SEE ATTACHED LITERATURE ARTICLE FOR REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779241 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION B35200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention SEE H11.