VERCISE? CARTESIA?
Report
- Report Number
- 3006630150-2025-05201
- Event Type
- Injury
- Date Received
- July 7, 2025
- Date of Event
- August 10, 2024
- Report Date
- September 9, 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
CORRECTION TO INITIAL MDR BSC AWARE DATE (G3): 24JUN2025. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7120341.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7120341, UDI: (B)(4).
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: 7120341.
CORRECTION TO SUPPLEMENTAL 1 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: 7120341, 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A POSTOPERATIVE HEMORRHAGE AND BILATERAL EDEMA WITHIN TWO WEEKS OF SURGERY. THESE COMPLICATIONS WERE EFFECTIVELY MANAGED AND RESOLVED THROUGH THE ADMINISTRATION OF CORTICOSTEROIDS.
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 EXPERIENCED A POSTOPERATIVE HEMORRHAGE AND BILATERAL EDEMA WITHIN TWO WEEKS OF SURGERY. THESE COMPLICATIONS WERE EFFECTIVELY MANAGED AND RESOLVED THROUGH THE ADMINISTRATION OF CORTICOSTEROIDS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT ALSO EXPERIENCED URINARY INCONTINENCE. THE BILATERAL-SIDED 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 DAYS 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.
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 EXPERIENCED A POSTOPERATIVE HEMORRHAGE AND BILATERAL EDEMA WITHIN TWO WEEKS OF SURGERY. THESE COMPLICATIONS WERE EFFECTIVELY MANAGED AND RESOLVED THROUGH THE ADMINISTRATION OF CORTICOSTEROIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2757761 | VERCISE? CARTESIA? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2202-45 | 7120265 | 08714729905288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |