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	Pain (1994); Shaking/Tremors (2515)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing pain and trimmers and the procedure was cancelled.The physician noted that there was not anything abnormal with the trial and that the patient may have some type of ocd.Also mentioned the patient was possibly going through withdraw because he had taken all of his pain medication the first night after the trial.X-rays were taken and the leads had little to no migration and remained posterior.
Event or Problem Description
It was reported that the patient was experiencing pain and trimmers and the procedure was cancelled.The physician noted that there was not anything abnormal with the trial and that the patient may have some type of ocd.Also mentioned the patient was possibly going through withdraw because he had taken all of his pain medication the first night after the trial.X-rays were taken and the leads had little to no migration and remained posterior.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Sc-5170, (sn: (b)(6).The returned ets was analyzed, passed all tests performed, and exhibited normal device characteristics.

• 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 MN ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15893548
• Report Number: 3006630150-2022-06661
• Device Sequence Number: 6689544
• Product Code: LGW
• UDI-Device Identifier: 08714729994657
• UDI-Public: 08714729994657
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 04/03/2023

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: 903267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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 Age: 49 YR
• Patient Sex: Male