MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-8436-70
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Pain (1994); Movement Disorder (4412)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the initial post operative programming session the patient did not receive adequate stimulation in the left arm from the paddle lead of the spinal cord stimulator (scs) system.It was then stated that the patient was feeling stimulation in their face.A computerized tomography scan (ct scan) was performed and confirmed that the bottom of the paddle lead was left sided.The patient underwent a revision procedure in which the paddle lead and the implantable pulse generator (ipg) were replaced.The patient is doing well post operatively.No devices will be returned as they were disposed of by the facility per protocol.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: (b)(6).

• Brand Name: COVEREDGE MRI
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19397923
• Report Number: 3006630150-2024-03384
• Device Sequence Number: 17904762
• Product Code: LGW
• UDI-Device Identifier: 08714729995821
• UDI-Public: 08714729995821
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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 Expiration Date: 02/21/2023
• Device Model Number: SC-8436-70
• Device Catalogue Number: SC-8436-70
• Device Lot Number: 7071098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/24/2024
• Date Device Manufactured: 02/21/2021
• 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: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male