VERCISE GENUS?
Report
- Report Number
- 3006630150-2025-03070
- Event Type
- Injury
- Date Received
- May 5, 2025
- Date of Event
- April 18, 2024
- Report Date
- April 8, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729985020
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTIONS TO INITIAL REPORT IN FIELD: H11. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7092442. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7092710. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7100064. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7100027. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. BATCH: 29406372.
CORRECTION TO INITIAL REPORT IN BLOCK: H11. BLOCK D2B; ADDITIONAL APPLICABLE PRODUCT CODES: MHY, PJS ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7092442 PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7092710 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6). BATCH: 7100064 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL:(B)(6) BATCH: 7100027 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C BATCH: 29406372 THE DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINTS, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7092442 PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7092710 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6). BATCH: 7100064 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6). BATCH: 7100027 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C BATCH: 29406372.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT SUFFERED A HEAD INJURY AT THE LEAD AND LEAD EXTENSION CONNECTION SITE, RESULTING IN EXPOSURE OF THE DEVICE AT THE CONNECTION POINT AND SUBSEQUENT INFECTION. A CULTURE WAS TAKEN, BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS IN GOOD CONDITION. THE MEDICAL FACILITY RETAINED THE DEVICES, SO THEY WILL NOT BE RETURNED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT SUFFERED A HEAD INJURY AT THE LEAD AND LEAD EXTENSION CONNECTION SITE, RESULTING IN EXPOSURE OF THE DEVICE AT THE CONNECTION POINT AND SUBSEQUENT INFECTION. A CULTURE WAS TAKEN, BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS IN GOOD CONDITION. THE MEDICAL FACILITY RETAINED THE DEVICES, SO THEY WILL NOT BE RETURNED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT SUFFERED A HEAD INJURY AT THE LEAD AND LEAD EXTENSION CONNECTION SITE, RESULTING IN EXPOSURE OF THE DEVICE AT THE CONNECTION POINT AND SUBSEQUENT INFECTION. A CULTURE WAS TAKEN, BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS IN GOOD CONDITION. THE MEDICAL FACILITY RETAINED THE DEVICES, SO THEY WILL NOT BE RETURNED.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT SUFFERED A HEAD INJURY AT THE LEAD AND LEAD EXTENSION CONNECTION SITE, RESULTING IN EXPOSURE OF THE DEVICE AT THE CONNECTION POINT AND SUBSEQUENT INFECTION. A CULTURE WAS TAKEN, BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS IN GOOD CONDITION. THE MEDICAL FACILITY RETAINED THE DEVICES, SO THEY WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1884397 | VERCISE GENUS? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-1416 | 206826 | 08714729985020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention |