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

Model Number	SC-4252
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an implant procedure, this tunneling tool packaging was opened in preparation for use and a hair was noted to be present within the sterile packaging.The tunneling tool was not used.The tool and packaging were discarded and were not returned for physical analysis.
Additional Manufacturer Narrative
This emdr was submitted as the regulatory assessment decision for this complaint was corrected due to a remediation effort associated with (b)(4).Block d2b additional pro codes: mhy, nhl, pjs.Media review was completed and it was confirmed there appeared to be a piece of hair in the outer pouch packaging layer.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of manufacturing deficiency.

• Brand Name: NA
• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25017714
• Report Number: 3006630150-2026-02686
• Device Sequence Number: 15829123
• Product Code: LGW
• UDI-Device Identifier: 08714729784456
• UDI-Public: (01)08714729784456(17)250806(10)31979800
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2025
• Device Model Number: SC-4252
• Device Catalogue Number: SC-4252
• Device Lot Number: 31979800
• 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: 04/09/2024
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 08/07/2023
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Male