VERCISE? CARTESIA?
Report
- Report Number
- 3006630150-2025-03931
- Event Type
- Injury
- Date Received
- June 4, 2025
- Date of Event
- April 3, 2025
- Report Date
- November 24, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729905288
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
CORRECTION TO SUPPLEMENTAL REPORT (2) IN BLOCK: H6. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7131036 UDI: (B)(4).
BLOCK B5 DESCRIBE EVENT OR PROBLEM: UPDATED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7131036. UDI: (B)(4).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
IT WAS REPORTED THAT THE DAY AFTER UNDERGOING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED BILATERAL EDEMA AT BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE LEADS, LEADING TO INFLAMMATION, PAIN, A BURNING AND STINGING SENSATION, AND DISCHARGE. BLOOD TESTS SHOWED NO ABNORMALITIES. IMAGING WAS CONDUCTED TO ACCURATELY DETERMINE THE LOCATION OF THE EDEMA, AND APPROPRIATE MEDICATION WAS ADMINISTERED TO MANAGE THE CONDITION. THE SWELLING HAS SINCE DIMINISHED WITH TREATMENT, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.
IT WAS REPORTED THAT THE DAY AFTER UNDERGOING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED BILATERAL EDEMA AT BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE LEADS, LEADING TO INFLAMMATION, PAIN, A BURNING AND STINGING SENSATION, AND DISCHARGE. BLOOD TESTS SHOWED NO ABNORMALITIES. IMAGING WAS CONDUCTED TO ACCURATELY DETERMINE THE LOCATION OF THE EDEMA, AND APPROPRIATE MEDICATION WAS ADMINISTERED TO MANAGE THE CONDITION. THE SWELLING HAS SINCE DIMINISHED WITH TREATMENT, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE DBS SYSTEM REMAINS ACTIVATED, AND THE PATIENT CONTINUES TO EXPERIENCE THERAPEUTIC BENEFIT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ADMINISTRATION OF STEROIDS LED TO SIGNIFICANT SYMPTOM RESOLUTION. ADDITIONAL INFORMATION WAS RECEIVED THAT EDEMA DEVELOPED 16 DAYS FOLLOWING THE DBS PROCEDURE AND PERSISTED FOR APPROXIMATELY TWO MONTHS AND 10 DAYS. DURING THIS PERIOD, THE PATIENT ALSO PRESENTED WITH HEMORRHAGE, COGNITIVE CHANGES, AND IMBALANCE. THE CONDITION RESOLVED FOLLOWING ADMINISTRATION OF CORTICOSTEROID THERAPY.
IT WAS REPORTED THAT THE DAY AFTER UNDERGOING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED BILATERAL EDEMA AT BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE LEADS, LEADING TO INFLAMMATION, PAIN, A BURNING AND STINGING SENSATION, AND DISCHARGE. BLOOD TESTS SHOWED NO ABNORMALITIES. IMAGING WAS CONDUCTED TO ACCURATELY DETERMINE THE LOCATION OF THE EDEMA, AND APPROPRIATE MEDICATION WAS ADMINISTERED TO MANAGE THE CONDITION. THE SWELLING HAS SINCE DIMINISHED WITH TREATMENT, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ADMINISTRATION OF STEROIDS LED TO SIGNIFICANT SYMPTOM RESOLUTION.
IT WAS REPORTED THAT THE DAY AFTER UNDERGOING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED BILATERAL EDEMA AT BOTH THE DISTAL AND PROXIMAL SEGMENTS OF THE LEADS, LEADING TO INFLAMMATION, PAIN, A BURNING AND STINGING SENSATION, AND DISCHARGE. BLOOD TESTS SHOWED NO ABNORMALITIES. IMAGING WAS CONDUCTED TO ACCURATELY DETERMINE THE LOCATION OF THE EDEMA, AND APPROPRIATE MEDICATION WAS ADMINISTERED TO MANAGE THE CONDITION. THE SWELLING HAS SINCE DIMINISHED WITH TREATMENT, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE DBS SYSTEM REMAINS ACTIVATED, AND THE PATIENT CONTINUES TO EXPERIENCE THERAPEUTIC BENEFIT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ADMINISTRATION OF STEROIDS LED TO SIGNIFICANT SYMPTOM RESOLUTION. ADDITIONAL INFORMATION WAS RECEIVED THAT EDEMA DEVELOPED 16 DAYS FOLLOWING THE DBS PROCEDURE AND PERSISTED FOR APPROXIMATELY TWO MONTHS AND 10 DAYS. DURING THIS PERIOD, THE PATIENT ALSO PRESENTED WITH HEMORRHAGE, COGNITIVE CHANGES, AND IMBALANCE. THE CONDITION RESOLVED FOLLOWING ADMINISTRATION OF CORTICOSTEROID THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 626248 | VERCISE? CARTESIA? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2202-45 | 7128411 | 08714729905288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |