MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SURETEK?; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	DB-4605-C
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this burr hole cover kit was used during a surgical procedure.The sterile packaging was opened and the contents of the kit were poured from the packaging onto the sterile field.After the contents were poured out, the surgical technician noted a hair on the outside of the inner packaging of this product.The decision was made to proceed with the use of this product since the hair did not contact the implanted products.The packaging was disposed of and was not returned for analysis.No adverse patient effects were reported.
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: nhl, pjs.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 cause not established.

• Brand Name: SURETEK?
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 25017909
• Report Number: 3006630150-2026-02708
• Device Sequence Number: 9506258
• Product Code: MHY
• UDI-Device Identifier: 08714729820819
• UDI-Public: (01)08714729820819(17)261009(10)34955955
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• 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 Model Number: DB-4605-C
• Device Catalogue Number: DB-4605-C
• Device Lot Number: 34955955
• 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: 03/18/2025
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 10/09/2024
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: Black Or African American