SOLETRA
Report
- Report Number
- 3007566237-2014-00001
- Event Type
- Injury
- Date Received
- January 2, 2014
- Date of Event
- February 13, 2013
- Report Date
- December 9, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_MICROELECTRODE, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).
THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_MICROELECTRODE, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENTS HAD RECOVERED. IT WAS NOTED THAT THERE WERE NO DEVICE MALFUNCTION OBSERVED.
UMEMURA, A., OKA, Y., YAMADA, K., OYAMA, G., SHIMO, Y., HATTORI, N. VALIDITY OF SINGLE TRACT MICROELECTRODE RECORDING IN SUBTHALAMIC NUCLEUS STIMULATION. NEUROLOGIA MEDICO-CHIRURGICA. 2013;53(11):821-827. DOI: 10.2176/NMC.OA2012-0412. SUMMARY: IN SURGERY FOR SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS), PRECISE IMPLANTATION OF THE LEAD INTO THE STN IS ESSENTIAL. PHYSIOLOGICAL REFINEMENT WITH MICROELECTRODE RECORDING (MER) IS THE GOLD STANDARD FOR IDENTIFYING STN. WE STUDIED SINGLE TRACT MER FINDINGS AND SURGICAL OUTCOMES AND VERIFIED OUR SURGICAL METHOD USING SINGLE TRACT MER. THE NUMBER OF TRAJECTORIES IN MER AND THE FINAL POSITION OF LEAD PLACEMENT WERE RETROSPECTIVELY ANALYZED IN 440 SIDES OF STN DBS IN 221 PATIENTS. BILATERAL STN DBS YIELDED MARKED IMPROVEMENT IN THE MOTOR SCORE, DYSKINESIA/FLUCTUATION SCORE, AND REDUCED REQUIREMENT OF DOPAMINERGIC MEDICATION IN THIS SERIES. THE NUMBER OF TRAJECTORIES REQUIRED TO OBTAIN SUFFICIENT ACTIVITY OF THE STN WAS ONE IN 79.0%, TWO IN 18.2%, AND THREE OR MORE IN 2.5% OF 440 SIDES. IN 92 SIDES REQUIRING ALTERED TRAJECTORY, THE FINAL DIRECTION OF TRAJECTORY MOVEMENT WAS POSTERIOR IN 73.9%, ANTERIOR IN 13.0%, LATERAL IN 5.4%, AND MEDIAL IN 4.3%. IN 18 PATIENTS, POSTERIOR MOVES WERE REQUIRED DUE TO SIGNIFICANT BRAIN SHIFT WITH INTRACRANIAL AIR CAUSED BY OUTFLOW OF CSF DURING THE SECOND SIDE PROCEDURE. SUFFICIENT STN ACTIVITY IS OBTAINED WITH MINIMUM TRAJECTORIES BY PROPER TARGETING AND PRECISE INTERPRETATION OF MER FINDINGS EVEN IN THE SINGLE TRACT METHOD. ANTERIOR¿POSTERIOR MOVES RATHER THAN MEDIAL¿LATERAL MOVES SHOULD BE ATTEMPTED FIRST IN CASES WITH INSUFFICIENT RECORDING OF STN ACTIVITY. REPORTED EVENTS: 1. ONE PATIENT WITH PARKINSON¿S DISEASE HAD A SYMPTOMATIC INTRACEREBRAL HEMORRHAGE (ICH) AT THE SITE OF THE LEAD IMPLANTATION. THE REPORTER STATED THAT THE HEMORRHAGE WAS IDENTIFIED BY UNEXPECTED ELECTRICAL SILENCE DURING MICROELECTRODE RECORDING (MER) AND SLIGHT BLEEDING FROM THE CANNULA. THE PROCEDURE WAS REPORTEDLY INTERRUPTED AND EMERGENCY COMPUTED TOMOGRAPHY (CT) CONFIRMED ICH. THE REPORTER STATED THAT THE FIRST LEAD HAD ALREADY BEEN SUCCESSFULLY IMPLANTED IN ONE SIDE AND THE IMPLANTATION HAD TO BE ABANDONED IN THE AFFECTED SIDE. IT WAS NOTED THAT THE NUMBER OF MICROELECTRODE TRACTS WAS TWO. THE REPORTER STATED THAT THE HEMATOMA DID NOT REQUIRE EVACUATION, BUT CAUSED HEMIPARESIS. THE PATIENT REPORTEDLY ¿MOSTLY RECOVERED¿ WITH REHABILITATION. THE PATIENT REPORTEDLY SHOWED PROLONGED HEMISPATIAL NEGLECT. THE REPORTER STATED THAT THE CARDINAL MOTOR SYMPTOMS OF THE PARKINSON¿S DISEASE SIGNIFICANTLY IMPROVED WITH PALLIDOTOMY-LIKE EFFECT BY HEMATOMA WITHOUT STIMULATION. 2. ONE PATIENT WITH PARKINSON¿S DISEASE HAD A SYMPTOMATIC INTRACEREBRAL HEMORRHAGE (ICH) AT THE SITE OF THE LEAD IMPLANTATION. THE REPORTER STATED THAT THE HEMORRHAGE WAS IDENTIFIED AFTER IMPLANTATION OF THE WHOLE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT REPORTEDLY SHOWED HEMIPARESIS AFTER RECOVERY FROM GENERAL ANESTHESIA FOR IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTATION. IT WAS NOTED THAT THE NUMBER OF MICROELECTRODE TRACTS WAS TWO. THE REPORTER STATED THAT THE HEMATOMA DID NOT REQUIRE EVACUATION. THE PATIENT REPORTEDLY ¿MOSTLY RECOVERED¿ WITH REHABILITATION. THE PATIENT REPORTEDLY SHOWED PROLONGED HEMISPATIAL NEGLECT. THE REPORTER STATED THAT THE CARDINAL MOTOR SYMPTOMS OF THE PARKINSON¿S DISEASE SIGNIFICANTLY IMPROVED WITH PALLIDOTOMY-LIKE EFFECT BY HEMATOMA WITHOUT STIMULATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |