SURETEK?
Report
- Report Number
- 3006630150-2026-00258
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- December 17, 2025
- Report Date
- May 19, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729820802
- PMA / PMN Number
- P150031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL.
CORRECTION TO BLOCK: H2. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL.
BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL.
THIS REPORT IS BEING SUBMITTED TO CORRECT THE UNIQUE IDENTIFIER (UDI) # FIELD (D4) IN SECTION D, SUSPECT MEDICAL DEVICE. CORRECTION TO BLOCK: H2. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: NHL.
IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) IMPLANTATION SURGERY, THE LEAD COULD NOT BE SECURED TO THE BASE USING THE BURR HOLE COVER'S (BHC) RETAINING CLIP. UPON CLOSER INSPECTION, IT APPEARED THAT THE RETAINING CLIP WAS BENT. THE ATTENDING PHYSICIAN MANUALLY ADJUSTED THE CLIP SLIGHTLY, ENABLING ATTACHMENT TO THE BASE AND USED IT AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE BHC WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT.
IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) IMPLANTATION SURGERY, THE LEAD COULD NOT BE SECURED TO THE BASE USING THE BURR HOLE COVER'S (BHC) RETAINING CLIP. UPON CLOSER INSPECTION, IT APPEARED THAT THE RETAINING CLIP WAS BENT. THE ATTENDING PHYSICIAN MANUALLY ADJUSTED THE CLIP SLIGHTLY, ENABLING ATTACHMENT TO THE BASE AND USED IT AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE BHC WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT.
IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) IMPLANTATION SURGERY, THE LEAD COULD NOT BE SECURED TO THE BASE USING THE BURR HOLE COVER'S (BHC) RETAINING CLIP. UPON CLOSER INSPECTION, IT APPEARED THAT THE RETAINING CLIP WAS BENT. THE ATTENDING PHYSICIAN MANUALLY ADJUSTED THE CLIP SLIGHTLY, ENABLING ATTACHMENT TO THE BASE AND USED IT AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE BHC WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT.
IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) IMPLANTATION SURGERY, THE LEAD COULD NOT BE SECURED TO THE BASE USING THE BURR HOLE COVER'S (BHC) RETAINING CLIP. UPON CLOSER INSPECTION, IT APPEARED THAT THE RETAINING CLIP WAS BENT. THE ATTENDING PHYSICIAN MANUALLY ADJUSTED THE CLIP SLIGHTLY, ENABLING ATTACHMENT TO THE BASE AND USED IT AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE BHC WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299370 | SURETEK? | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-4600-C | 36688962 | 08714729820802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |