MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION PRECISION ?; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-4230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Paralysis (1997)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced a loss of motor control of the right leg following the use of the passing elevator during the scs implant procedure.Additionally, the patients blood pressure had increased intraoperatively.Therefore, the physician aborted the scs implant procedure and proceeded with a laminectomy with no devices implanted.The patients sensory and motor control returned to baseline postoperatively and the patient was able to move all extremities normally.
Additional Manufacturer Narrative
Correction to the initial mdr in block b1.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced a loss of motor control of the right leg following the use of the passing elevator during the scs implant procedure.Additionally, the patients blood pressure had increased intraoperatively.Therefore, the physician aborted the scs implant procedure and proceeded with a laminectomy with no devices implanted.The patients sensory and motor control returned to baseline postoperatively and the patient was able to move all extremities normally.
Additional Manufacturer Narrative
Device analysis performed on the returned passing elevator revealed normal device characteristics during visual inspection.As there was no allegation against the functionality of the device and the patients sensory and motor control returned to normal postoperatively, engineers concluded that the adverse event was related to the procedure.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced a loss of motor control of the right leg following the use of the passing elevator during the scs implant procedure.Additionally, the patients blood pressure had increased intraoperatively.Therefore, the physician aborted the scs implant procedure and proceeded with a laminectomy with no devices implanted.The patients sensory and motor control returned to baseline postoperatively and the patient was able to move all extremities normally.

• Brand Name: PRECISION ?
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21405280
• Report Number: 3006630150-2025-00835
• Device Sequence Number: 15847035
• Product Code: LGW
• UDI-Device Identifier: 08714729767572
• UDI-Public: (01)08714729767572(17)261125(10)35307687
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SC-4230
• Device Catalogue Number: SC-4230
• Device Lot Number: 35307687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 01/08/2026
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/07/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female