STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Report
- Report Number
- 3006630150-2025-05178
- Event Type
- Injury
- Date Received
- July 4, 2025
- Date of Event
- June 6, 2025
- Report Date
- March 26, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729966395
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12320, MODEL: DB-1232, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4).
CORRECTION TO BLOCKS: B2, H6. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12320 MODEL: DB-1232 SERIAL: (B)(6). BATCH: 553835 UDI: (B)(4). PRODUCT FAMILY: UPN: M365DB2203450 MODEL: DB-2203-45 SERIAL: (B)(6). BATCH: 5002318 UDI: (B)(4). PRODUCT FAMILY: UPN: M365DB3216550 MODEL: DB-3216-55 SERIAL: (B)(6). BATCH: 5001458 UDI: (B)(4).
THE DEVICES WERE RETAINED BY THE FACILITY AND NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A LABELING REVIEW WAS PERFORMED ON THE DEVICE'S INSTRUCTIONS FOR USE (IFU). THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
CORRECTION TO BLOCKS: B2, H6. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12320, MODEL: DB-1232, SERIAL: (B)(6), BATCH: 553835, UDI: (B)(4). PRODUCT FAMILY: UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002318, UDI: (B)(4). PRODUCT FAMILY: UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001458, UDI: (B)(4).
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE INVOLVING COMPLETE REMOVAL OF THE DBS SYSTEM DUE TO INFECTION. THE PATIENT EXHIBITED FLUID DISCHARGE AT THE EXTENSION SITE. THE PATIENT REMAINS IN RECOVERY, AND ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION. THE HOSPITAL HAS RETAINED THE EXPLANTED DEVICES, AND THEY WILL NOT BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE INVOLVING COMPLETE REMOVAL OF THE DBS SYSTEM DUE TO INFECTION. THE PATIENT EXHIBITED FLUID DISCHARGE AT THE EXTENSION SITE. THE PATIENT REMAINS IN RECOVERY, AND ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION. THE HOSPITAL HAS RETAINED THE EXPLANTED DEVICES, AND THEY WILL NOT BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE INVOLVING COMPLETE REMOVAL OF THE DBS SYSTEM DUE TO INFECTION. THE PATIENT EXHIBITED FLUID DISCHARGE AT THE EXTENSION SITE. THE PATIENT REMAINS IN RECOVERY, AND ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION. THE HOSPITAL HAS RETAINED THE EXPLANTED DEVICES, AND THEY WILL NOT BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE INVOLVING COMPLETE REMOVAL OF THE DBS SYSTEM DUE TO INFECTION. THE PATIENT EXHIBITED FLUID DISCHARGE AT THE EXTENSION SITE. THE PATIENT REMAINS IN RECOVERY, AND ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION. THE HOSPITAL HAS RETAINED THE EXPLANTED DEVICES, AND THEY WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484344 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-3216-55 | 5001779 | 08714729966395 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Hospitalization| R |