VERCISE? CARTESIA?
Report
- Report Number
- 3006630150-2025-03387
- Event Type
- Injury
- Date Received
- May 15, 2025
- Date of Event
- April 20, 2025
- Report Date
- September 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7130787. UDI: (B)(4).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7130787 UDI: (B)(4).
CORRECTION TO INITIAL REPORT IN BLOCK: 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: (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. 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.
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. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED BILATERAL PERI-LEAD EDEMA TWO MONTHS FOLLOWING THE DBS LEAD IMPLANTATION PROCEDURE. THE EDEMA PERSISTED FOR APPROXIMATELY THREE MONTHS AND WAS ASSOCIATED WITH WORSENING PARKINSONS DISEASE SYMPTOMS, IMBALANCE, AND A LEFT-SIDED SUBARACHNOID HEMORRHAGE. CORTICOSTEROID THERAPY WAS ADMINISTERED, AND RESOLUTION OF THE EVENT WAS CONFIRMED BY IMAGING AFTER THREE MONTHS. HOWEVER, CLINICAL IMBALANCE PERSISTS. THE DBS SYSTEM REMAINS ACTIVE, AND THE PATIENT CONTINUES TO EXPERIENCE THERAPEUTIC BENEFIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88758 | VERCISE? CARTESIA? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2202-45 | 7130897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |