SENSIGHT
Received May 20, 2025 · Event occurred May 14, 2025
Report 2182207-2025-01360 · MDR key 22055536
Device
Generic name
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Manufacturer
Quality Tech Services LlcModel number
B3301542Catalog number
B3301542
Product problems
- Activation, Positioning or Separation Problem
- Adverse Event Without Identified Device or Use Problem
- Activation, Positioning or Separation Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CONTINUATION OF D10: PRODUCT ID B31000 LOT# 082T06424 SERIAL# IMPLANTED:(B)(6) 2025 EXPLANTED: (B)(6) 2025 PRODUCT TYPE ACCESSORY SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: B31000, SERIAL/LOT #: (B)(6) UBD: 04-MAR-2026, UDI#: (B)(4). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE INVOLVING THE BURR HOLE DEVICE, THE SCREWS WERE DIFFICULT OR IMPOSSIBLE TO INSERT INTO THE SKULL CAP, AND THE SUPPORT CLIP COULD NOT BE CLICKED INTO THE BASE. NO EXTERNAL FACTORS CONTRIBUTED TO THE ISSUE, AND NO TROUBLESHOOTING WAS PERFORMED. THE RESOLUTION INVOLVED USING A NEW DEVICE, AND THE PRODUCT WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
CONTINUATION OF D10: PRODUCT ID B31000 LOT# 082T06424 IMPLANTED: (B)(6) 2025 EXPLANTED: (B)(6) 2025 PRODUCT TYPE ACCESSORY H6: REMOVED ANNEX A CODE A24 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.