MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Linear? 3-4; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-2352-50
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Battery Problem (2885); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product code: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-2352-50.Serial number: (b)(6) batch/lot number: 7082562.Model/catalog description: linear 3-4 lead 50 cm.Unique identifier (udi)#: (b)(4).Model number/catalog number: sc-1416.Serial number: (b)(6).Batch/lot number: 231313.Model/catalog description: wavewriter alpha prime 16 ipg kit.Unique identifier (udi)#: (b)(4).
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation due to spinal cord stimulator (scs) lead migrated following a motor vehicle accident.It was also stated that the patient's implantable pulse generator (ipg) had reached end of life due to high energy usage secondary to lead migration.No device malfunction was suspected.The patient underwent a procedure wherein the ipg was replaced and the leads were repositioned.The patient was doing well postoperatively and the explanted ipg was retained by the medical facility and will not be returned.

• Brand Name: Linear? 3-4
• Common Device Name: stimulator, spinal-cord, totally implanted for pain relief
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 25901388
• Report Number: 3006630150-2026-05226
• Device Sequence Number: 5791270
• Product Code: LGW
• UDI-Device Identifier: 08714729789550
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/20/2026
• Device Model Number: SC-2352-50
• Device Catalogue Number: SC-2352-50
• Device Lot Number: 7082093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 08/20/2024
• 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: 74 YR
• Patient Sex: Female