MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION CoverEdge? 32; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-8336-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Muscle Weakness/Atrophy (1967); Pain (1994); Paralysis (1997)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a spinal cord stimulator (scs) implant procedure and was initially reported to be recovering without complications.Two days following the implant procedure, the patient presented to the emergency department with thoracic pain and weakness/paralysis from the umbilical region downward.An mri was performed and confirmed the presence of an epidural hematoma.The physician assessed the event as procedure related.The scs system was explanted the following morning.The patient was discharged from the hospital on the same day as the explant procedure and transferred to a rehabilitation facility for recovery.At the time of reporting, the patient was undergoing rehabilitation, and a full recovery was anticipated.Attempts to obtain updated information regarding the patient's recovery status have been unsuccessful, as no response has been received from the rehabilitation center.The explanted devices will not be returned as they disposed by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-1232, serial number: (b)(6), batch/lot number: 808131, model/catalog description: wavewriter alpha 32 ipg kit, unique identifier (udi): (b)(4).

• 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; PR 00646-2602
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50088888
• Report Number: 3006630150-2026-05420
• Device Sequence Number: 10478856
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: (01)08714729832669(17)280426(10)7095037
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 7095037
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 04/27/2026
• 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: Required Intervention; Life Threatening
• Patient Sex: Male