STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Report
- Report Number
- 3006630150-2025-05066
- Event Type
- Injury
- Date Received
- July 2, 2025
- Date of Event
- May 14, 2025
- Report Date
- April 24, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729966340
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION TO FIELD B2: UPDATED THE SELECTION TO INCLUDE DEATH AND UPDATED DATE OF DEATH.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5003333, UDI: (B)(4).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED A BRAIN BLEED IN THE RIGHT HEMISPHERE NEAR THE TOP OF THE BRAIN. THE PATIENT EXPERIENCED SIGNIFICANT MOMENTS OF CONFUSION AND SUNDOWNING IN THE EVENING. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER PASSED AWAY FROM RENAL FAILURE AND HYPONATREMIA. ADDITIONAL INFORMATION WAS RECEIVED PROVING THE PATIENTS DATE OF DEATH.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED A BRAIN BLEED IN THE RIGHT HEMISPHERE NEAR THE TOP OF THE BRAIN. THE PATIENT EXPERIENCED SIGNIFICANT MOMENTS OF CONFUSION AND SUNDOWNING IN THE EVENING. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER PASSED AWAY FROM RENAL FAILURE AND HYPONATREMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152439 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2203-45 | 5003246 | 08714729966340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Required Intervention| H |