BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 22642788 · Received July 29, 2025

    Report

    Report Number
    9612501-2025-02063
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 5, 2023
    Report Date
    July 30, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    ADDITIONAL REVIEW INDICATED THE EVENT CAPTURED IN THIS REPORT PERTAINED TO THE EVENT PREVIOUSLY REPORTED UNDER REGULATORY REPORT 2021898-2023-00063. ANY FURTHER INFORMATION FOR THE EVENT WILL BE REPORTED UNDER THE REFERENCED REPORT. 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

    LAURA C. TILLMAN, WALTER H. TRUONG, SARA J. MORGAN, TENNER J. GUILLAUME. AN IN VIVO ANALYSIS OF IMPLANTED PROGRAMMABLE DEVICE INTERFERENCE DURING MAGNETICALLY CONTROLLED GROWING ROD LENGTHENINGS: A STORY OF 129 LENGTHENINGS. SPINE DEFORMITY 11 (2023). DOI: 10.1007/S43390-023-00709-7 ABSTRACT PURPOSE: EARLY-ONSET SCOLIOSIS (EOS) IS OFTEN TREATED WITH MAGNETICALLY CONTROLLED GROWING RODS (MCGR) WHICH CAN BE LENGTHENED WITH A MAGNETIC EXTERNAL REMOTE CONTROL (ERC). MANY INDIVIDUALS WITH EOS HAVE CONCOMITANT MEDICAL CONDITIONS WHICH ARE MANAGED WITH OTHER IMPLANTED PROGRAMMABLE DEVICES (IPD). SOME PROVIDERS ARE CONCERNED THAT THE MAGNETIC FIELD GENERATED DURING MCGR LENGTHENING MAY INTERFERE WITH OTHER IPD, SUCH AS VENTRICULOPERITONEAL SHUNTS (VPS), INTRATHECAL BACLOFEN PUMPS (ITBP), VAGAL NERVE STIMULATORS (VNS), AND COCHLEAR IMPLANTS (CI). THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY OF MCGR LENGTHENINGS IN PATIENTS WITH EOS AND OTHER IPD. METHODS: THIS SINGLE-CENTER, SINGLE-SURGEON CASE SERIES FOLLOWED 12 PATIENTS WITH 13 IPD AS THEY UNDERWENT TREATMENT WITH MCGR. POST MCGR LENGTHENING, MONITORING OF PATIENT SYMPTOMS, AND INTERROGATION OF IPD WERE CONDUCTED TO EVALUATE FOR MAGNETIC INTERFERENCE. RESULTS: AFTER 129 MCGR LENGTHENINGS, POST-LENGTHENING VPS INTERROGATION FOUND 2 INSTANCES OF POTENTIAL INTERFERENCE IN SETTINGS (BOTH IN MEDTRONIC STRATA SHUNTS); HOWEVER, NO PRE-LENGTHENING INTERROGATION WAS COMPLETED TO CONFIRM IF THESE CHANGES OCCURRED PRIOR TO OR DURING THE LENGTHENING PROCEDURE. ITBP INTERROGATION FOUND NO CHANGES, AND THERE WERE NO PATIENT-REPORTED ADVERSE EFFECTS RELATED TO VNS OR CI FUNCTION. CONCLUSION: IT IS SAFE AND EFFECTIVE TO UTILIZE MCGR IN PATIENTS WITH IPD. HOWEVER, THE POSSIBILITY OF MAGNETIC INTERFERENCE MUST BE CONSIDERED, PARTICULARLY IN INDIVIDUALS WITH VPS. WE RECOMMEND APPROACHING WITH THE ERC FROM A CAUDAL DIRECTION TO MINIMIZE POTENTIAL INTERFERENCE AND ALL PATIENTS BE MONITORED DURING TREATMENT. IF POSSIBLE, IPD SETTINGS SHOULD BE ASSESSED PRE-LENGTHENING, CONFIRMED AFTERWARDS AND READJUSTED IF NECESSARY. REPORTED EVENTS - DURING THE STUDY PERIOD, THERE WERE A TOTAL OF 129 LENGTHENING SESSIONS AMONG THE 12 PATIENTS. ACROSS ALL LENGTHENING SESSIONS, THERE WERE TWO INSTANCES OF POTENTIAL MAGNETIC INTERFERENCE. THESE INSTANCES OCCURRED IN TWO PATIENTS WITH VPS, BOTH OF WHICH WERE MEDTRONIC STRATA SHUNTS. POST LENGTHENING SHUNT INTERROGATION REVEALED THAT SETTINGS WERE DIFFERENT FROM WHAT WAS PREVIOUSLY DOCUMENTED. A PROVIDER FROM THE NEUROSURGICAL TEAM EVALUATED BOTH PATIENTS AND RESET THE SHUNTS TO THEIR APPROPRIATE SETTINGS. ONE OF THE AFFECTED PATIENTS SUBSEQUENTLY REPORTED MILD SYMPTOMS OF SHUNT MALFUNCTION IN THE 2 WEEKS PRIOR TO THE MCGR LENGTHENING FOLLOWING AN MRI OBTAINED AT AN OUTSIDE CLINIC. PARENTS OF THIS CHILD REPORTED QUESTIONING THE SHUNT SETTING AFTER MRI AND REPORTED LOW CONFIDENCE IN THE PROVIDER WHO REPROGRAMMED THE SHUNT FOLLOWING THAT PROCEDURE. ALL 22 PRECEDING AND SUBSEQUENT LENGTHENINGS IN BOTH PATIENTS WERE UNEVENTFUL, AS WERE THE 73 LENGTHENINGS IN OTHER PATIENTS WITH VPS. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383964 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown