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 Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced overstimulation from spinal cord stimulator (scs) device.It was also reported that the scs lead had migrated and was causing pain.The patient underwent an scs system explant procedure.No further information could be obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in the year of 2017.Block d6b: explant date: 2017 additional suspect medical device components involved in the event: model number/catalog number: sc-1132 serial number: (b)(6) batch/lot number: 17387956 model/catalog description: precision spectra ipg kit unique identifier (udi) #: (b)(4) model number/catalog number: sc-4316 serial number: n/a batch/lot number: 17222141 model/catalog description: clik anchor 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; 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: 50897724
• Report Number: 3006630150-2026-07082
• Device Sequence Number: 14952607
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: (01)08714729832676(17)150916(10)16338980
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 09/16/2015
• Device Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 16338980
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Female