EXTERNAL NEUROSTIMULATOR
Report
- Report Number
- 2182207-2023-01427
- Event Type
- Malfunction
- Date Received
- July 20, 2023
- Date of Event
- June 8, 2023
- Report Date
- October 20, 2023
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD PRODUCT ID: NEU_ENS_STIMULATOR. PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD; PRODUCT ID: NEU_ENS_STIMULATOR; PRODUCT ID: NEU_UNKNOWN_LEAD. IESS G., BONOMO G., LEVI V., AQUINO D., ZEKAJ E., MEZZA F., SERVELLO D. MER AND INCREASED OPERATIVE TIME ARE NOT RISK FACTORS FOR THE FORMATION OF PNEUMOCEPHALUS DURING DBS. SCI REP. 2023;13(1):9324. DOI:10.1038/S41598-023-30289-5 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. 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. 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. 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.
CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. 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.
IESS G., BONOMO G., LEVI V., AQUINO D., ZEKAJ E., MEZZA F., SERVELLO D. MER AND INCREASED OPERATIVE TIME ARE NOT RISK FACTORS FOR THE FORMATION OF PNEUMOCEPHALUS DURING DBS. SCI REP. 2023;13(1):9324. DOI:10.1038/S41598-023-30289-5 ALTHOUGH ONLY RECENTLY DIRECTIONAL LEADS HAVE PROVEN THEIR POTENTIAL TO COMPENSATE FOR SUB-OPTIMALLY PLACED ELECTRODES, OPTIMAL LEAD POSITIONING REMAINS THE MOST CRITICAL FACTOR IN DETERMINING DEEP BRAIN STIMULATION (DBS) OUTCOME. PNEUMOCEPHALUS IS A RECOGNIZED SOURCE OF ERROR, BUT THE FACTORS THAT CONTRIBUTE TO ITS FORMATION ARE STILL A MATTER OF DEBATE. AMONG THESE, OPERATIVE TIME IS ONE OF THE MOST CONTROVERSIAL. BECAUSE CASES OF DBS PERFORMED WITH MICROELECTRODE RECORDINGS (MER) ARE AFFECTED BY AN INCREASE IN SURGICAL LENGTH, IT IS USEFUL TO ANALYZE WHETHER MER PLACES PATIENTS AT RISK FOR INCREASED INTRACRANIAL AIR ENTRY. DATA OF 94 PATIENTS FROM TWO DIFFERENT INSTITUTES WHO UNDERWENT DBS FOR DIFFERENT NEUROLOGIC AND PSYCHIATRIC CONDITIONS WERE ANALYZED FOR THE PRESENCE OF POSTOPERATIVE PNEUMOCEPHALUS. OPERATIVE TIME AND USE OF MER, AS WELL AS OTHER POTENTIAL RISK FACTORS FOR PNEUMOCEPHALUS (AGE, AWAKE VS. ASLEEP SURGERY, NUMBER OF MER PASSAGES, BURR HOLE SIZE, TARGET AND UNILATERAL VS. BILATERAL IMPLANTS) WERE EXAMINED. MANN-WHITNEY U AND KRUSKAL-WALLIS TESTS WEREUTILIZED TO COMPARE INTRACRANIAL AIR DISTRIBUTIONS ACROSS GROUPS OF CATEGORICAL VARIABLES. PARTIAL CORRELATIONS WERE USED TO ASSESS THE ASSOCIATION BETWEEN TIME AND VOLUME. A GENERALIZED LINEAR MODEL WAS CREATED TO PREDICT THE EFFECTS OF TIME AND MER ON THE VOLUME OF INTRACRANIAL AIR, CONTROLLING FOR OTHER POTENTIAL RISK FACTORS IDENTIFIED: AGE, NUMBER OF MER PASSAGES, AWAKE VS. ASLEEP SURGERY, BURR HOLE SIZE, TARGET, UNILATERAL VS. BILATERAL SURGERY. SIGNIFICANTLY DIFFERENT DISTRIBUTIONS OF AIR VOLUME WERE NOTED BETWEEN DIFFERENT TARGETS, UNILATERAL VS. BILATERAL IMPLANTS, AND NUMBER OF MER TRAJECTORIES. PATIENTS UNDERGOING DBS WITH MER DID NOT PRESENT A SIGNIFICANT INCREASE IN PNEUMOCEPHALUS COMPARED TO PATIENTS OPERATED WITHOUT (P = 0.067). NO SIGNIFICANT CORRELATION WAS FOUND BETWEEN PNEUMOCEPHALUS AND TIME. USING MULTIVARIATE ANALYSIS, UNILATERAL IMPLANTS EXHIBITED LOWER VOLUMES OF PNEUMOCEPHALUS (P = 0.002). TWO SPECIFIC TARGETS EXHIBITED SIGNIFICANTLY DIFFERENT VOLUMES OF PNEUMOCEPHALUS: THE BED NUCLEUS OF THE STRIA TERMINALIS WITH LOWER VOLUMES (P <(><<)> 0.001) AND THE POSTERIOR HYPOTHALAMUS WITH HIGHER VOLUMES (P = 0.011). MER, TIME, AND OTHER PARAMETERS ANALYZED FAILED TO REACH STATISTICAL SIGNIFICANCE. OPERATIVE TIME AND USE OF INTRAOPERATIVE MER ARE NOT SIGNIFICANT PREDICTORS OF PNEUMOCEPHALUS DURING DBS. AIR ENTRY IS GREATER FOR BILATERAL SURGERIES AND MAY BE ALSO INFLUENCED BY THE SPECIFIC STIMULATED TARGET. REPORTED EVENTS: 1. FOR INSTITUTE 1, IF MER AND/OR CLINICAL TESTING SUGGESTED AN INACCURATE ELECTRODE PLACEMENT, A SECOND TRAJECTORY IS USED. 20% OF THE DBS SURGERIES REQUIRED TWO TRAJECTORIES. 2. FOR INSTITUTE 1, 10% OF THE DBS SURGERIES REQUIRED THREE OR MORE TRAJECTORIES.
2023-OCT-14 E1 (FOR, HCP): ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT AND CLARIFIED THAT MOST OF THE "TWO OR MULTIPLE TRAJECTORIES" CASES LISTED WERE ACTUALLY CASES IN WHICH MORE THAN ONE STIMULATING ELECTRODES WERE USED AS A RESULT OF SUBOPTIMAL MICROELECRODE RECORDINGS AND/OR MACROSTIMULATIONS, NOT REAL PERMANENT ELECTRODE EXPLANTATIONS. THEREFORE THEY WERE NOT CONSIDERED "EVENTS" (I.E., COMPLICATIONS). BECAUSE THEY WERE ALSO INTERESTED IN STUDYING WHETHER THE EFFECT OF MULTIPLE PIERCES (I.E., MULTIPLE TRAJECTORIES) THROUGH THE ARACHNOID COULD HAVE ACTED AS A CONFOUNDER OF THE VOLUME OF AIR ENTERED DURING THE PROCEDURES, WE INCLUDED THIS INDEPENDENT VARIABLE IN THE ANALYSIS, BUT IT'S IMPORTANT TO UNDERLINE ONCE AGAIN THAT THESE WERE NOT REAL ELECTRODE EXPLANATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37239 | EXTERNAL NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | "SEE H10...." |