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

Model Number	SC-3138-35
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant procedure, under which the patient was sedated with general anesthesia, of the spinal cord stimulator (scs) system, the lead extension could not be disconnected.The physician cut the silicon and removed the screw block, and was still unable to disconnect the lead extension, indicating that the screw block was too tight.The physician decided to abort the procedure.
Additional Manufacturer Narrative
The lead extension was returned and visual inspection of the lead extension revealed that the connector block was separated from connector.The set screw was received loose from the connector block.The lead extension tail was cut from the lead extension connector, and it wasn't returned.The connector silicon also has multiple cuts.The borescope inspection of the lead extension connector and its connector block revealed no anomalies.A known good lead was inserted and removed from the connector block and lead extension connector without any difficulty.The set screw was tightened on the known good lead and it was removed without any anomalies.A labeling review was performed on the device instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers are not able to confirm the root cause of the event.The device was returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is unable to determine a probable root cause for the complaint and the conclusion is cause not established.
Event or Problem Description
It was reported that during the implant procedure to implant the implantable pulse generator (ipg) of the spinal cord stimulator (scs) system, under which the patient was sedated with general anesthesia, the lead extension could not be disconnected from the lead.The physician cut the silicon and removed the screw block, and was still unable to disconnect the lead extension from the lead, based on his assumption indicating that the screw block was too tight.The lead extension was ultimately removed and the procedure completed, leaving the lead implanted.The patient is receiving adequate pain relief.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21770362
• Report Number: 3006630150-2025-02134
• Device Sequence Number: 9821982
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: 08714729760559
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: Lay User/Patient
• Device Expiration Date: 10/25/2025
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 7084444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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 Sex: Unknown