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

Model Number	SC-9218-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2024 additional suspect medical device component involved in the event: product family: scs-adapters, upn: m365sc9218150, model: sc-9218-15, serial: (b)(6), batch: 7062053.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced a cyst formation at the adapter site.The physician assessed that the adapters were rubbing together and causing irritation resulting in the cyst formation.Therefore, the patient underwent a surgical procedure to investigate the site and a culture was taken.Culture results revealed a low-grade staphylococcal growth.The patient was recovering with no complications post operatively.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2024.Additional suspect medical device components involved in the event: product family: scs-adapters.Upn: m365sc9218150.Model: sc-9218-15.Serial: (b)(6).Batch: 7062053.Product family: scs-ipg-r-mri.Upn: m365sc12320.Model: sc-1232.Serial: (b)(6).Batch: 540614 product family: scs-linear leads.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: (b)(6).Product family: scs-linear leads.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: (b)(6).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced a cyst formation at the adapter site.The physician assessed that the adapters were rubbing together and causing irritation resulting in the cyst formation.Therefore, the patient underwent a surgical procedure to investigate the site and a culture was taken.Culture results revealed a low-grade staphylococcal growth.The patient was recovering with no complications post operatively.Additional information was provided that the patient was given intravenous antibiotics during the procedure to investigate the site.Additionally, the patient underwent an explant procedure at a later date where the full scs system was explanted.There were no patient complications postoperatively.The explanted devices will not be returned as they were retained by the medical facility.

• Brand Name: PRECISION
• 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: 18853238
• Report Number: 3006630150-2024-01259
• Device Sequence Number: 7245859
• Product Code: LGW
• UDI-Device Identifier: 08714729888734
• UDI-Public: 08714729888734
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 04/19/2024
• Device Model Number: SC-9218-15
• Device Catalogue Number: SC-9218-15
• Device Lot Number: 7073808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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 Sex: Unknown