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 Code	Pain (1994)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient, that is enrolled in the (b)(6) clinical trial, experienced worsened neuropathic left lower extremity pain.The patient was prescribed non-opioid medications.The patient's stimulation was not yet turned on.The event is resolving.The non-serious adverse event was reported as causally related to procedure and not related to device hardware and or stimulation.
Event or Problem Description
It was reported that the patient, that is enrolled in the (b)(4) clinical trial, experienced worsened neuropathic left lower extremity pain.The patient was prescribed non-opioid medications.The patient's stimulation was not yet turned on.The event is resolving.The non-serious adverse event was reported by the investigator as causally related to procedure and not related to device hardware and or stimulation.Additional information was received that the event resolved.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 14258156
• Report Number: 3006630150-2022-01943
• Device Sequence Number: 1559479
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-5170
• Device Catalogue Number: SC-5170
• Device Lot Number: 905087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 05/02/2022
• Supplement Report FDA Received Date: 11/22/2022
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Female