VERCISE
Report
- Report Number
- 3006630150-2025-06145
- Event Type
- Injury
- Date Received
- August 4, 2025
- Date of Event
- July 10, 2025
- Report Date
- September 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7080663, UDI: (B)(4).
THE RETURNED DBS LEAD EXTENSION SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL CHARACTERISTICS. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. ADDITIONALLY, LABELING STATES DISCOMFORT AND FIBROSIS SUCH AS THICKENED SKIN AND SCARRING AROUND THE LEAD EXTENSION ARE KNOWN RISKS WITH THE USE OF THE DBS. THE REPORTED EVENT WAS NOT CONFIRMED FOR THE HIGH IMPEDANCE. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES PROBABLE CAUSE WAS NO PROBLEM DETECTED, THE RETURNED DBS LEAD EXTENSION SERIAL NUMBER (B)(6) WAS ANALYZED, AND X-RAY INSPECTION REVEALED TWO CABLES WERE FRACTURED AFTER THE WELD IN THE DISTAL CONNECTOR STACK, HOWEVER REMAINED CONTAINED INSIDE CONNECTOR, THIS TYPE OF DAMAGE OCCURS WHEN EXCESSIVE WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD EXTENSION BODY AND CONNECTOR SECTIONS. THE REPORTED EVENT OF HIGH IMPEDANCES WAS CONFIRMED THEREFORE BOSTON SCIENTIFIC CONCLUDES PROBABLE CAUSE WAS CAUSED TRACED TO COMPONENT FAILURE, A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. ADDITIONALLY, LABELING STATES FAILURE OR MALFUNCTION OF ANY OF THE DEVICE COMPONENTS OR THE BATTERY, INCLUDING BUT NOT LIMITED TO THE LEAD EXTENSION BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, WHETHER OR NOT THIS REQUIRES SURGICAL INTERVENTION, INCLUDING DISCOMFORT AND FIBROSIS SUCH AS THICKENED SKIN AND SCARRING AROUND THE LEAD EXTENSION ARE KNOWN RISKS WITH THE USE OF THE DBS.
IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, HIGH IMPEDANCES WERE IDENTIFIED ON THE DEEP BRAIN STIMULATION (DBS) DEVICE. CLINICAL EVALUATION INDICATED THAT SCAR TISSUE HAD FORMED AROUND THE LEAD EXTENSIONS, CAUSING BOWSTRINGING AND RESULTING IN CERVICAL SPINE DISCOMFORT DUE TO REDUCED RANGE OF MOTION. THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE LEAD EXTENSIONS, WHICH WAS COMPLETED SUCCESSFULLY. THE PATIENT DID WELL POST-OPERATIVELY.
IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, HIGH IMPEDANCES WERE IDENTIFIED ON THE DEEP BRAIN STIMULATION (DBS) DEVICE. CLINICAL EVALUATION INDICATED THAT SCAR TISSUE HAD FORMED AROUND THE LEAD EXTENSIONS, CAUSING BOWSTRINGING AND RESULTING IN CERVICAL SPINE DISCOMFORT DUE TO REDUCED RANGE OF MOTION. THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE LEAD EXTENSIONS, WHICH WAS COMPLETED SUCCESSFULLY. THE PATIENT DID WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2277487 | VERCISE | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | NM-3138-55 | 7080709 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |