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

Model Number	SC-4254
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician encountered difficulty while tunneling to implant a deep brain stimulation lead.The physician believed the tunneling tool was too flexible, which led to hemorrhaging and blood loss in the patient during the surgery.A non-boston scientific tunneling tool was used to complete the procedure and the patient was hospitalized.The device will not be returned as it was discarded by the medical facility.
Event or Problem Description
It was reported that the physician encountered difficulty while tunneling to implant a deep brain stimulation lead.The physician believed the tunneling tool was too flexible, which led to hemorrhaging and blood loss in the patient during the surgery.A non-boston scientific tunneling tool was used to complete the procedure and the patient was hospitalized.The device will not be returned as it was discarded by the medical facility.Additional information received that adaptive anesthesia, and compresses were done in response to the hemorrhaging.

• 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: 20488281
• Report Number: 3006630150-2024-07121
• Device Sequence Number: 17170293
• Product Code: LGW
• UDI-Device Identifier: 08714729762751
• UDI-Public: 08714729762751
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: Health Professional
• Device Expiration Date: 04/26/2025
• Device Model Number: SC-4254
• Device Catalogue Number: SC-4254
• Device Lot Number: 31484920
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/20/2024
• Date Device Manufactured: 04/27/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown