NA
Report
- Report Number
- 3006630150-2025-07826
- Event Type
- Injury
- Date Received
- September 19, 2025
- Date of Event
- February 19, 2025
- Report Date
- October 29, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729820765
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>.
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>.
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>.
IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DBS EXTENSION WAS REPLACED DUE TO HIGH IMPEDANCES. THE PATIENT'S SYMPTOMS INCLUDED LOSS OF TREMOR CONTROL AND A SUBSEQUENT CHANGE IN PROGRAMMING. THE DEVICE WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS STABLE.
IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DBS EXTENSION WAS REPLACED DUE TO HIGH IMPEDANCES. THE PATIENT'S SYMPTOMS INCLUDED LOSS OF TREMOR CONTROL AND A SUBSEQUENT CHANGE IN PROGRAMMING. THE DEVICE WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS STABLE.
IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1397765 | NA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | NM-3138-55 | 7104407 | 08714729820765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Required Intervention |