VERCISE GENUS?
Report
- Report Number
- 3006630150-2026-01459
- Event Type
- Injury
- Date Received
- March 12, 2026
- Date of Event
- February 17, 2026
- Report Date
- April 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729985044
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS WAS UNABLE TO BE PERFORMED. HOWEVER, IT WAS CONFIRMED THE DEVICES MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED. BLOCK D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <NHL> ADDITIONAL SUSPECT MEDICAL DEVICES COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-9218-15, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7073223, MODEL/CATALOG DESCRIPTION: VERCISE M8 ADAPTER 15CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-9218-15, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7073423, MODEL/CATALOG DESCRIPTION: VERCISE M8 ADAPTER 15CM, UNIQUE IDENTIFIER (UDI) #: (B)(4).
BLOCK D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <NHL> ADDITIONAL SUSPECT MEDICAL DEVICES COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-9218-15 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7073223 MODEL/CATALOG DESCRIPTION: VERCISE M8 ADAPTER 15CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-9218-15 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7073423 MODEL/CATALOG DESCRIPTION: VERCISE M8 ADAPTER 15CM UNIQUE IDENTIFIER (UDI) #: (B)(4).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND ADAPTERS WERE REPLACED DUE TO PROGRESSION OF THEIR PRE-EXISTING PARKINSON'S DISEASE FOR WHICH THERAPY WAS LIMITED DUE TO THE HARDWARE TYPE OF THE IMPLANTED DBS SYSTEM. THE PHYSICIAN DID NOT SUSPECT ANY DEVICE ISSUES. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND ADAPTERS WERE REPLACED DUE TO PROGRESSION OF THEIR PRE-EXISTING PARKINSON'S DISEASE FOR WHICH THERAPY WAS LIMITED DUE TO THE HARDWARE TYPE OF THE IMPLANTED DBS SYSTEM. THE PHYSICIAN DID NOT SUSPECT ANY DEVICE ISSUES. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495393 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1216 | 537441 | 08714729985044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention |