MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION COVEREDGE? 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-8336-70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750)
Date of Event	09/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, explant date used as the approximated date of event.Additional suspect medical device component involved in the event: model number/catalog number: sc-1232.Serial number: (b)(6).Batch/lot number: 768079.Model/catalog description: wavewriter alpha 32 ipg kit.Unique identifier (udi)#: (b)(4).
Event or Problem Description
It was reported that the patient had developed an infection which caused the incision site to open and the leads exposed out of the skin.The patient was provided with antibiotics.The patient underwent a spinal cord stimulator (scs) explant procedure.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported that the patient had developed an infection which caused the incision site to open and the leads exposed out of the skin.The patient was provided with antibiotics.The patient underwent a spinal cord stimulator (scs) explant procedure.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however response was not received.Device history record it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Additional suspect medical device component involved in the event: model number/catalog number: sc-1232 serial number: (b)(6) batch/lot number: 768079 model/catalog description: wavewriter alpha 32 ipg kit unique identifier (udi)#: (b)(4) block b3: exact date unknown, explant date used as the approximated date of event.

• Brand Name: COVEREDGE? 32
• 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; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25059615
• Report Number: 3006630150-2026-02823
• Device Sequence Number: 21189015
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: (01)08714729832676(17)260213(10)7075801
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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: 02/13/2026
• Device Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 7075801
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 07/10/2026
• Date Device Manufactured: 02/14/2024
• 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: 50 YR
• Patient Sex: Female