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	High Blood Pressure/ Hypertension (1908); Muscle Weakness/Atrophy (1967); Pain (1994); Tachycardia (2095); Numbness (2415); Bladder Dysfunction (4881); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced pain, weakness, numbness, proprioceptive deficits, paresthesia, and urinary retention, accompanied by episodes of hypertensive crisis and tachycardia.The patient was referred to a local representative for reprogramming; however, it is unknown whether reprogramming was performed.The physician attempted nerve blocks, radiofrequency treatment, and additional scs therapy to address the symptoms, but these interventions were unsuccessful.The patients symptoms were reported to progressively worsen over time.Subsequently, the patient underwent explantation of the lead and implantable pulse generator (ipg).Postoperatively, the patient demonstrated improvement and continued recovery of sensation, proprioception, and muscle control.It was further reported that the attending physician attributed the symptoms to a programming issue and did not pursue additional evaluation, prompting the patient to seek a second opinion.The patient subsequently developed permanent neurologic and autonomic dysfunction resulting in disability.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model/catalog description: unk-ipg.Model: unk-ipg.Serial: n/a.Batch: n/a.Udi: n/a.

• 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: 50859087
• Report Number: 3006630150-2026-07001
• Device Sequence Number: 9497864
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 01/07/2020
• Device Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 7005161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 01/07/2018
• 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: Disability; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 160 LB