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	05/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced cramping during the trial period with a competitive lead connected to a boston scientific external trial stimulator (ets).The physician assessed that this is a common side effect, but the patient was kept in the hospital for observation and the event subsided after a few hours.

• 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
• MDR Report Key: 11968627
• Report Number: 3006630150-2021-02760
• Device Sequence Number: 4414882
• Product Code: LGW
• UDI-Device Identifier: 08714729994657
• UDI-Public: 08714729994657
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: 900456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other