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

Model Number	SC-1110-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient passed away.The cause of death is not believed to be related to stimulation; however, it remains unconfirmed.Physicians office does not have a record of patient passing away.No further information has been obtained.
Additional Manufacturer Narrative
Block d.2b; additional applicable product codes: qrb.Additional suspect medical device components involved in the event: model number/catalog number: sc-8216-70 serial number: (b)(6) batch/lot number: 13984940 model/catalog description: artisan lead 70 cm unique identifier (udi) #:(b)(4).Model number/catalog number: sc-4316 serial number: n/a batch/lot number: 14302395 model/catalog description: clik anchor unique identifier (udi) #: (b)(4).

• Brand Name: Precision?
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50803186
• Report Number: 3006630150-2026-06855
• Device Sequence Number: 12910800
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: (01)08714729767688(17)130401(10)14268044
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2013
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 14268044
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• 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: Death
• Patient Age: 62 YR
• Patient Sex: Male