EXTERNAL NEUROSTIMULATOR
Report
- Report Number
- 2182207-2024-00435
- Event Type
- Injury
- Date Received
- February 5, 2024
- Date of Event
- December 19, 2023
- Report Date
- June 7, 2024
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME LEAD; PRODUCT ID NEU_UNKNOWN_LEAD (SERIAL: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE BRAND NAME LEAD; PRODUCT ID NEU_UNKNOWN_LEAD (SERIAL: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE G2: CITATION: AUTHORS: SUCCOP JR. B. S., ZAMORA C., ROQUE D. A., HADAR E., KESSLER B., QUINSEY C.. DAY ONE POSTOPERATIVE MRI FINDING FOLLOWING ELECTRODE PLACEMENT FOR DEEP BRAIN STIMULATION: ANALYSIS OF A LARGE CASE SERIES. FRONTIERS IN NEUROLOGY 2023. DOI: 10.3389/FNEUR.2023.1253241 · 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. REFER TO MANUFACTURER'S REPORT 2182207-2024-00434 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT. 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.
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.
SUCCOP JR. B. S., ZAMORA C., ROQUE D. A., HADAR E., KESSLER B., QUINSEY C. DAY ONE POSTOPERATIVE MRI FINDING FOLLOWING ELECTRODE PLACEMENT FOR DEEP BRAIN STIMULATION: ANALYSIS OF A LARGE CASE SERIES FRONTIERS IN NEUROLOGY 2023 DOI: 10.3389/FNEUR.2023.1253241. ABSTRACT: OBJECTIVE: THIS STUDY SOUGHT TO CHARACTERIZE POSTOPERATIVE DAY ONE MRI FINDINGS IN DEEP BRAIN STIMULATION (DBS) PATIENTS. METHODS: DBS PATIENTS WERE IDENTIFIED BY CPT AND HAD THEIR REVIEWED BY A TRAINED NEURORADIOLOGIST AND NEUROSURGEON BLINDED TO MR SEQUENCE AND PATIENT INFORMATION. THE RADIOGRAPHIC ABNORMALITIES OF INTEREST WERE TRACK MICROHEMORRHAGE, PNEUMOCEPHALUS, HEMATOMAS, AND EDEMA, AND THE OCCURRENCE OF THESE FINDINGS IN COMPARE THE DETECTION OF THESE COMPLICATIONS BETWEEN T1/T2 GRADIENT-ECHO (GRE) AND T1/T2 FLUI D-ATTENUATED INVERSION RECOVERY (FLAIR) MAGNETIC RESONANCE (MR) SEQUENCES WAS COMPARED. THE PRESENCE, SIZE, AND ASSOCIATION OF SUSCEPTIBILITY ARTIFACT WITH OTHER RADIOGRAPHIC ABNORMALITIES WAS ALSO DESCRIBED. LASTLY, THE ASSOCIATION OF MULTIPLE MICROELECTRODE CANNULA PASSES WITH EACH RADIOGRAPHIC FINDING WAS EVALUATED. AD-HOC INVESTIGATION EVALUATED HEMISPHERE-SPECIFIC ASSOCIATIONS. MULTIPLE L OGISTIC REGRESSION WITH BONFERRONI CORRECTION (CORRECTED P = 0.006) WAS USED FOR ALL ANALYSIS. RESULTS: OUT OF 198 DBS PATIENTS REVIEWED, 115 (58%) PATIENTS SHOWED ENTRY MICROHEMORRHAGE; 77 (39%) TRACK MICROHEMORRHAGE; 44 (22%) EDEMA; 69 (35%) PNEUMOCEPHALUS; AND 12 (6%) INTRACRANIAL HEMATOMA. T2 GRE WAS BETTER FOR DETECTING MICROHEMORRHAGE (OR = 14.82, P <(><<)> 0.0001 FOR ENTRY SITE AND OR = 4.03, P <(><<)> 0.0001 FOR TRACK) AND PNEUMOCEPHALUS (OR = 11.86, P <(><<)> 0.0001), WHILE T2 FLAIR WAS BETTER AT DETECTING EDEMA (OR = 123.6, P <(><<)> 0.0001). THE RELATIVELY COMMON FINDINGS OF MICROHEMORRHAGE AND EDEMA WERE BEST VISUALIZED BY T2 GRE AND T2 FLAIR SEQUENCES, RESPECTIVELY. MORE PASSES INTRAOPERATIVELY WAS ASSOCIATED WITH DETECTION OF IPSILATERAL TRACK MICROHEMORRHAGE (OR = 7.151, P <(> <<)> 0.0001 LEFT; OR = 8.953, P <(><<)> 0.0001 RIGHT). SUSCEPTIBILITY ARTIFACT SURROUNDING ELECTRODES POSSIBLY INTERFERED WITH FURTHER DETECTION OF IPSILATERAL EDEMA (OR = 4.323, P = 0.0025 LEFT HEMISPHERE ONLY). DISCUSSION: DAY ONE POSTOPERATIVE MAGNETIC RESONANCE IMAGING (MRI) FOR DBS PATIENTS CAN BE USED TO DETECT NUMEROUS RADIOGRAPHIC ABNORMALITIES NOT IDENTIFIABLE ON A COMPUTED TOMOGRAPHIC (CT) SCAN. FOR THIS COHORT, MULTIPLE STIMULATING CANNULA PASSES INTRAOPERATIVELY WAS ASSOCIATED WITH INCREASED MICROHEMORRHAGE ALONG THE ELECTRODE TRACK. FURTHER STUDIES SHOULD BE PERFORMED TO EVALUATE THE CLINICAL RELEVANCE OF THESE OBSERVATIONS. REPORTED EVENTS: 32 RIGHT HEMISPHERE LEADS REQUIRED MULTIPLE PASSES. 32 LEFT HEMISPHERE LEADS REQUIRED MULTIPLE PASSES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) STATING THAT THE ADVERSE EVENTS WERE NOT DIRECTLY RELATED TO THE MEDTRONIC DEVICES, AND THE EVENTS WERE ALL SECONDARY TO THE SURGERY. THE CAUSE OF THE MULTIPLE PASSES WERE DUE TO A FAILURE TO OBTAIN DESIRED THERAPEUTIC RESULTS WITH STIMULATION ON INITIAL PASS.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WHILE THEY DO NOT HAVE THE EXACT BREAKDOWNS BY PATIENT, THE CAUSE OF FAILURE ON INITIAL PASS WERE EITHER LACK OF THERAPEUTIC RESULT OR UNWANTED SIDE EFFECTS AT THE SITE OF STIMULATION. THE CAUSE OF SOME LEADS HAVING ASYMMETRICALLY LARGER SUSCEPTIBILITY ARTIFACTS WAS NOT DETERMINED AND WAS AN OUTSTANDING QUESTION LEFTOVER. NO STEPS WERE TAKEN TO RESOLVE THESE ARTIFACTS. THE ISSUE DID RESOLVE, ALL PATIENTS EVENTUALLY OBTAINED THERAPEUTIC STIMULATION AND NONE OF THE COMPLICATIONS REPORTED IN THE MANUSCRIPT WERE PERMANENT OR RECURRING. HOWEVER, SOME ARTIFACTS DID PERSIST IN SOME PATIENTS FOLLOW UP IMAGING FOR UNKNOWN REASONS. FURTHER WORK IS NEEDED TO EVALUATE WHY ARTIFACT IS ENHANCED ASYMMETRICALLY IN SOME PATIENTS.
SUCCOP JR. B. S., ZAMORA C., ROQUE D. A., HADAR E., KESSLER B., QUINSEY C. DAY ONE POSTOPERATIVE MRI FINDING FOLLOWING ELECTRODE PLACEMENT FOR DEEP BRAIN STIMULATION: ANALYSIS OF A LARGE CASE SERIES FRONTIERS IN NEUROLOGY 2023 DOI: 10.3389/FNEUR.2023.1253241 ABSTRACT: OBJECTIVE: THIS STUDY SOUGHT TO CHARACTERIZE POSTOPERATIVE DAY ONE MRI FINDINGS IN DEEP BRAIN STIMULATION (DBS) PATIENTS. METHODS: DBS PATIENTS WERE IDENTIFIED BY CPT AND HAD THEIR REVIEWED BY A TRAINED NEURORADIOLOGIST AND NEUROSURGEON BLINDED TO MR SEQUENCE AND PATIENT INFORMATION. THE RADIOGRAPHIC ABNORMALITIES OF INTEREST WERE TRACK MICROHEMORRHAGE, PNEUMOCEPHALUS, HEMATOMAS, AND EDEMA, AND THE OCCURRENCE OF THESE FINDINGS IN COMPARE THE DETECTION OF THESE COMPLICATIONS BETWEEN T1/T2 GRADIENT-ECHO (GRE) AND T1/T2 FLUI D-ATTENUATED INVERSION RECOVERY (FLAIR) MAGNETIC RESONANCE (MR) SEQUENCES WAS COMPARED. THE PRESENCE, SIZE, AND ASSOCIATION OF SUSCEPTIBILITY ARTIFACT WITH OTHER RADIOGRAPHIC ABNORMALITIES WAS ALSO DESCRIBED. LASTLY, THE ASSOCIATION OF MULTIPLE MICROELECTRODE CANNULA PASSES WITH EACH RADIOGRAPHIC FINDING WAS EVALUATED. AD-HOC INVESTIGATION EVALUATED HEMISPHERE-SPECIFIC ASSOCIATIONS. MULTIPLE L OGISTIC REGRESSION WITH BONFERRONI CORRECTION (CORRECTED P = 0.006) WAS USED FOR ALL ANALYSIS. RESULTS: OUT OF 198 DBS PATIENTS REVIEWED, 115 (58%) PATIENTS SHOWED ENTRY MICROHEMORRHAGE; 77 (39%) TRACK MICROHEMORRHAGE; 44 (22%) EDEMA; 69 (35%) PNEUMOCEPHALUS; AND 12 (6%) INTRACRANIAL HEMATOMA. T2 GRE WAS BETTER FOR DETECTING MICROHEMORRHAGE (OR = 14.82, P <(><<)> 0.0001 FOR ENTRY SITE AND OR = 4.03, P <(><<)> 0.0001 FOR TRACK) AND PNEUMOCEPHALUS (OR = 11.86, P <(><<)> 0.0001), WHILE T2 FLAIR WAS BETTER AT DETECTING EDEMA (OR = 123.6, P <(><<)> 0.0001). THE RELATIVELY COMMON FINDINGS OF MICROHEMORRHAGE AND EDEMA WERE BEST VISUALIZED BY T2 GRE AND T2 FLAIR SEQUENCES, RESPECTIVELY. MORE PASSES INTRAOPERATIVELY WAS ASSOCIATED WITH DETECTION OF IPSILATERAL TRACK MICROHEMORRHAGE (OR = 7.151, P <(> <<)> 0.0001 LEFT; OR = 8.953, P <(><<)> 0.0001 RIGHT). SUSCEPTIBILITY ARTIFACT SURROUNDING ELECTRODES POSSIBLY INTERFERED WITH FURTHER DETECTION OF IPSILATERAL EDEMA (OR = 4.323, P = 0.0025 LEFT HEMISPHERE ONLY). DISCUSSION: DAY ONE POSTOPERATIVE MAGNETIC RESONANCE IMAGING (MRI) FOR DBS PATIENTS CAN BE USED TO DETECT NUMEROUS RADIOGRAPHIC ABNORMALITIES NOT IDENTIFIABLE ON A COMPUTED TOMOGRAPHIC (CT) SCAN. FOR THIS COHORT, MULTIPLE STIMULATING CANNULA PASSES INTRAOPERATIVELY WAS ASSOCIATED WITH INCREASED MICROHEMORRHAGE ALONG THE ELECTRODE TRACK. FURTHER STUDIES SHOULD BE PERFORMED TO EVALUATE THE CLINICAL RELEVANCE OF THESE OBSERVATIONS. REPORTED EVENTS: 1) 32 RIGHT HEMISPHERE LEADS REQUIRED MULTIPLE PASSES. 2) 32 LEFT HEMISPHERE LEADS REQUIRED MULTIPLE PASSES.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) STATING THAT THE ADVERSE EVENTS WERE NOT DIRECTLY RELATED TO THE MEDTRONIC DEVICES, AND THE EVENTS WERE ALL SECONDARY TO THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495405 | EXTERNAL NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | SEE H10... |