VERCISE
Report
- Report Number
- 3006630150-2022-06962
- Event Type
- Injury
- Date Received
- December 13, 2022
- Date of Event
- November 22, 2022
- Report Date
- March 13, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 08714729905196
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE; UPN: M365DB9218550; MODEL: DB-9218-55; SERIAL: NO INFORMATION; BATCH: NO INFORMATION.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE. UPN: M365DB9218550. MODEL: DB-9218-55. SERIAL: (B)(4). BATCH: 7072849. DEVICE TECHNICAL ANALYSIS: DB-9218-55; 7072858: VISUAL INSPECTION REVEALED THAT THE TOP TWO CONTACTS ARE SEPARATED FROM THE PROXIMAL END, X-RAY INSPECTION OF THE M8 ADAPTERS REVEALED THAT CABLE 2 WAS FRACTURED AFTER THE WELD IN THE DISTAL CONNECTOR STACK AND WAS ALSO PULLED, CONTACTS 1 AND 2 WERE NOT RETURNED. IT APPEARS THAT EXCESSIVE TENSILE FORCE WAS EXERTED ON THE TOP TWO CONTACTS RESULTING IN ITS SEPARATION AND CABLES TO BE PULLED BETWEEN CONTACTS 3 TO 8, AND ARE EXPOSED AT THE FRACTURE LOCATION. IT IS UNLIKELY FOR THE ADAPTER PROXIMAL END TO BE DAMAGED WHILE IT IS IMPLANTED AND INSERTED INTO AN IPG PORT AS THE PROXIMAL ARRAY IS WELL PROTECTED WITHIN THE IPG PORT. THE DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ASIDE FROM THE 2 DAMAGED PROXIMAL CONTACTS. DB-9218-55; 7072849: THE M8 ADAPTER WAS RETURNED AND ANALYZED, NO ANOMALIES WERE FOUND. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED ON THE DEVICES INSTRUCTIONS FOR USE, IFU, AND IT DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT FAILURE OR MALFUNCTION OF ANY OF THE DEVICE COMPONENTS OR THE BATTERY, INCLUDING BUT NOT LIMITED TO LEAD OR EXTENSION BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, WHETHER OR NOT THIS REQUIRES EXPLANT AND/OR RE-IMPLANTATION AND LOSS OF ADEQUATE STIMULATION ARE KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE NOT ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE M8 ADAPTERS WERE RETURNED AND ANALYZED, AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION CONCLUDES THAT NO PROBLEM WAS DETECTED.
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE, UPN: M365DB9218550, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7072849. DB-9218-55; 7072858: VISUAL INSPECTION REVEALED THAT THE TOP TWO CONTACTS ARE SEPARATED FROM THE PROXIMAL END. X-RAY INSPECTION OF THE M8 LEAD ADAPTER REVEALED THAT CABLE 2 WAS FRACTURED AND PULLED AFTER THE WELD IN THE DISTAL CONNECTOR STACK. CONTACTS 1 AND 2 WERE NOT RETURNED. IT APPEARS THAT EXCESSIVE TENSILE FORCE WAS EXERTED ON THE TOP TWO CONTACTS RESULTING IN THE SEPARATION. EXCESSIVE TENSILE FORCE ALSO CAUSED THE CABLES TO BE PULLED BETWEEN CONTACTS 3 TO 8; THE CABLES ARE EXPOSED AT THE FRACTURE LOCATION. IT IS UNLIKELY FOR THE ADAPTER PROXIMAL END TO BE DAMAGED WHILE IT IS IMPLANTED AND INSERTED INTO AN IMPLANTABLE PULSE GENERATOR (IPG) PORT AS THE PROXIMAL ARRAY IS WELL PROTECTED WITHIN THE IPG PORT. THE DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ASIDE FROM THE 2 DAMAGED PROXIMAL CONTACTS. DB-9218-55; 7072849: THE M8 LEAD ADAPTER WAS RETURNED, ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A LABELING REVIEW WAS PERFORMED, AND IT DID NOT REVEAL ANY ANOMALIES. THE INSTRUCTIONS FOR USE (IFU) STATES THAT FAILURE OR MALFUNCTION OF ANY OF THE DEVICE COMPONENTS OR THE BATTERY, INCLUDING BUT NOT LIMITED TO LEAD OR EXTENSION BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, AND LOSS OF ADEQUATE STIMULATION ARE KNOWN RISKS WITH THE USE OF DEEP BRAIN STIMULATION. BASED ON AVAILABLE INFORMATION, A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE M8 LEAD ADAPTERS CONFIRMED THAT THE DEVICES PASSED ALL REQUIRED SPECIFICATIONS AND TESTING PRIOR TO BEING RELEASED FOR DISTRIBUTION/SALE. A LABELING REVIEW WHICH INDICATED THAT THE EVENTS OF HIGH IMPEDANCE AND THE PATIENT NOT RECEIVING RELIEF ARE KNOWN RISKS ASSOCIATED WITH THE USE OF DBS. THE RETURNED DEVICES WERE ANALYZED AND NO PROBLEMS WERE FOUND, HOWEVER ENGINEERS DETERMINED THAT CONTACTS ON ONE OF THE LEAD ADAPTERS WERE LIKELY DAMAGED DURING THE EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE. THEREFORE, NO PROBLEM WAS DETECTED.
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE M8 ADAPTERS AFTER THE PATIENT UNDERWENT AN UNRELATED PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG POCKET WAS OPENED AND THE M8 ADAPTERS WERE REPLACED. THE HIGH IMPEDANCES RESOLVED AND THE PATIENT IS DOING WELL POST OPERATIVELY.
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE M8 ADAPTERS AFTER THE PATIENT UNDERWENT AN UNRELATED PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IPG POCKET WAS OPENED AND THE M8 ADAPTERS WERE REPLACED. THE HIGH IMPEDANCES RESOLVED AND THE PATIENT IS DOING WELL POST OPERATIVELY.
IT WAS REPORTED THAT HIGH IMPEDANCES WERE NOTED ON THE M8 LEAD ADAPTERS AFTER THE PATIENT UNDERWENT NON-DEVICE RELATED PROCEDURE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE M8 LEAD ADAPTERS WERE REPLACED. THE HIGH IMPEDANCES RESOLVED AND THE PATIENT IS DOING WELL POSTOPERATIVELY. IT WAS ADDITIONALLY REPORTED THAT THE TWO CONTACTS THAT CAME OFF OF THE DEVICE DID SO DURING THE EXTRACTION PROCESS. THE PHYSICIAN CONFIRMED THE CONTACTS WERE REMOVED FROM THE PATIENT'S BODY AND WERE DISPOSED OF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406820 | VERCISE | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION | DB-9218-15 | 7072858 | 08714729905196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |