VERCISE? CARTESIA?
Report
- Report Number
- 3006630150-2025-05225
- Event Type
- Injury
- Date Received
- July 7, 2025
- Date of Event
- May 19, 2025
- Report Date
- September 10, 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 B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7133086.
CORRECTION TO INITIAL REPORT IN BLOCK: B5. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7133086. UDI: (B)(4).
CORRECTION TO INITIAL MDR BSC AWARE DATE (G3): 04JUL2025. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7133086. UDI: (B)(4).
IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED LOCALIZED EDEMA AT THE DISTAL END OF THE LEAD, RESULTING IN INFLAMMATION AND SWELLING. ADDITIONAL UNSPECIFIED SIDE EFFECTS WERE ALSO REPORTED. ADMINISTRATION OF CORTICOSTEROIDS LED TO SIGNIFICANT SYMPTOM RESOLUTION. COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED TO ASSESS THE CONDITION.
IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED LOCALIZED EDEMA AT THE DISTAL END OF THE LEAD, RESULTING IN INFLAMMATION AND SWELLING. ADDITIONAL UNSPECIFIED SIDE EFFECTS WERE ALSO REPORTED. ADMINISTRATION OF CORTICOSTEROIDS LED TO SIGNIFICANT SYMPTOM RESOLUTION. COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED TO ASSESS THE CONDITION. THE PATIENTS DBS SYSTEM WAS PROGRAMMED, AND THE PATIENT WAS DERIVING A BENEFIT FROM IT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED BILATERAL EDEMA WITHIN TWO WEEKS POSTOPERATIVELY, WHICH WAS EFFECTIVELY RESOLVED FOLLOWING CORTICOSTEROID THERAPY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BILATERAL PERI-LEAD EDEMA PERSISTED FOR A DURATION OF APPROXIMATELY ONE WEEK TO ONE MONTH PRIOR TO RESOLUTION. INITIAL SYMPTOM IMPROVEMENT WAS OBSERVED WITHIN 5 TO 7 DAYS TO 1 MONTH FOLLOWING THE ONSET OF TREATMENT.
IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED LOCALIZED EDEMA AT THE DISTAL END OF THE LEAD, RESULTING IN INFLAMMATION AND SWELLING. ADDITIONAL UNSPECIFIED SIDE EFFECTS WERE ALSO REPORTED. ADMINISTRATION OF CORTICOSTEROIDS LED TO SIGNIFICANT SYMPTOM RESOLUTION. COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED TO ASSESS THE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DEVELOPED BILATERAL EDEMA WITHIN TWO WEEKS POSTOPERATIVELY, WHICH WAS EFFECTIVELY RESOLVED FOLLOWING CORTICOSTEROID THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7730 | VERCISE? CARTESIA? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2202-45 | 7132057 | 08714729905288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |