VERCISE? CARTESIA?
Report
- Report Number
- 3006630150-2025-03396
- Event Type
- Injury
- Date Received
- May 15, 2025
- Date of Event
- April 30, 2025
- Report Date
- July 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729905271
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7078432. 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: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(6). BATCH: 7078432. 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: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7078432.
IT WAS REPORTED THAT FOLLOWING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED DELIRIUM. THE PHYSICIAN ATTRIBUTED THIS EVENT TO A MICRO-DESTRUCTIVE EFFECT FOLLOWING LEAD PLACEMENT. AS THE PATIENT WAS ALREADY HOSPITALIZED POST-IMPLANT, HE REMAINED UNDER MEDICAL CARE. THE DELIRIUM HAS SINCE SUBSIDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL.
IT WAS REPORTED THAT FOLLOWING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED DELIRIUM. THE PHYSICIAN ATTRIBUTED THIS EVENT TO A MICRO-DESTRUCTIVE EFFECT FOLLOWING LEAD PLACEMENT. AS THE PATIENT WAS ALREADY HOSPITALIZED POST-IMPLANT, HE REMAINED UNDER MEDICAL CARE. THE DELIRIUM HAS SINCE SUBSIDED.
IT WAS REPORTED THAT FOLLOWING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PATIENT DEVELOPED DELIRIUM. THE PHYSICIAN ATTRIBUTED THIS EVENT TO A MICRO-DESTRUCTIVE EFFECT FOLLOWING LEAD PLACEMENT. AS THE PATIENT WAS ALREADY HOSPITALIZED POST-IMPLANT, HE REMAINED UNDER MEDICAL CARE. THE DELIRIUM HAS SINCE SUBSIDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. PSYCHIATRIC SYMPTOMS REMAIN UNDER ONGOING OBSERVATION AND CLINICAL MONITORING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1896078 | VERCISE? CARTESIA? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2202-30 | 7078432 | 08714729905271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Hospitalization| R |