NA
Report
- Report Number
- 3006630150-2025-05984
- Event Type
- Injury
- Date Received
- July 30, 2025
- Date of Event
- January 1, 2025
- Report Date
- February 25, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- NHL
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7104456. UDI: (B)(4).
CORRECTION TO INITIAL REPORT IN SECTION: H11. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: MHY AND PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7104456, UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 546826, UDI: (B)(4).
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-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7104456. UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: UNK. BATCH: UNK. UDI: UNK.
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-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A DEEP BRAIN STIMULATION (DBS) SYSTEM EXPERIENCED POST-OPERATIVE HEALING COMPLICATIONS, INCLUDING TISSUE EROSION AT THE INCISION SITE LOCATED BEHIND THE LEFT EAR. THE PATIENT WAS TREATED WITH ANTIBIOTICS. A REVISION PROCEDURE HAS BEEN PLANNED, AND THE EVENT REMAINS ONGOING AND UNDER CLINICAL ASSESSMENT.
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A DEEP BRAIN STIMULATION (DBS) SYSTEM EXPERIENCED POST-OPERATIVE HEALING COMPLICATIONS, INCLUDING TISSUE EROSION AT THE INCISION SITE LOCATED BEHIND THE LEFT EAR. THE PATIENT WAS TREATED WITH ANTIBIOTICS. A REVISION PROCEDURE HAS BEEN PLANNED, AND THE EVENT REMAINS ONGOING AND UNDER CLINICAL ASSESSMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED WITH THE EXTENSION PROTRUDING FROM THE SKIN. THE PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEFT EXTENSION AND ASSOCIATED IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. A NEW EXTENSION WAS IMPLANTED AND CONNECTED TO AN EXISTING IPG. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS HEALING.
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A DEEP BRAIN STIMULATION (DBS) SYSTEM EXPERIENCED POST-OPERATIVE HEALING COMPLICATIONS, INCLUDING TISSUE EROSION AT THE INCISION SITE LOCATED BEHIND THE LEFT EAR. THE PATIENT WAS TREATED WITH ANTIBIOTICS. A REVISION PROCEDURE HAS BEEN PLANNED, AND THE EVENT REMAINS ONGOING AND UNDER CLINICAL ASSESSMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED WITH THE EXTENSION PROTRUDING FROM THE SKIN. THE PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE LEFT EXTENSION AND ASSOCIATED IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. A NEW EXTENSION WAS IMPLANTED AND CONNECTED TO AN EXISTING IPG.
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A DEEP BRAIN STIMULATION (DBS) SYSTEM EXPERIENCED POST-OPERATIVE HEALING COMPLICATIONS, INCLUDING TISSUE EROSION AT THE INCISION SITE LOCATED BEHIND THE LEFT EAR. THE PATIENT WAS TREATED WITH ANTIBIOTICS. A REVISION PROCEDURE HAS BEEN PLANNED, AND THE EVENT REMAINS ONGOING AND UNDER CLINICAL ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612146 | NA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | NHL | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | NM-3138-55 | 7090324 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention |