MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SCS EXTERNAL TRIAL STIMULATOR - BLE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-5170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post spinal cord stimulation implant procedure the patient experienced muscle spasms in the left lower back.The physician suspected lead placement may have been the cause of the muscle spasm.The physician administered a muscle relaxer and the patient was doing ok.The investigators reported the relationship to procedure was reported as possible.The relationship to device stimulation was reported as possible.

• Brand Name: SCS EXTERNAL TRIAL STIMULATOR - BLE
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14025152
• Report Number: 3006630150-2022-01489
• Device Sequence Number: 2595789
• Product Code: LGW
• UDI-Device Identifier: 08714729994657
• UDI-Public: 08714729994657
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SC-5170
• Device Catalogue Number: SC-5170
• Device Lot Number: 905058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown