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

Model Number	SC-2218-70E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Speech Disorder (4415)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads; upn: m365sc221870e0, model: sc-2218-70e, serial: (b)(6), batch: 7081073.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient became sick to her stomach a day after the trial implant procedure and in the morning when she woke up, she was unable to speak normally.The patient experienced a seizure and was transported to the emergency room (er).The physician does not believe that the seizure was device related.The trial leads were explanted to perform imaging and bloodwork.The patient was doing fine post-operatively and has not experienced any further seizures.The explanted trial leads were not returned per medical facility policy.

• Brand Name: LINEAR ST
• 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: 16878584
• Report Number: 3006630150-2023-02525
• Device Sequence Number: 7256505
• Product Code: LGW
• UDI-Device Identifier: 08714729820741
• UDI-Public: 08714729820741
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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 Expiration Date: 09/02/2023
• Device Model Number: SC-2218-70E
• Device Catalogue Number: SC-2218-70E
• Device Lot Number: 7081063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female