MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; 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); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure it was not possible disconnect the temporary lead extension from the lead.A procedure in which surgical dissection of the lead extension was performed.
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that during the procedure it was not possible disconnect the temporary lead extension from the lead.A procedure in which surgical dissection of the lead extension was performed.It was additionally reported that due to the extended trial period, between the initial trial implant and the implantable pulse generator (ipg), a lot of fibrosis tissue developed around the electrode and extension bodies.It is not known why there was over a month between the implant dates.During the procedure it was discovered that the lead extension migrated, the physician used force to pull the lead extension causing it to break and leaving the prominent end of the lead extension implanted.Due to the force used by the physician to pull the lead extension out two contacts became dislodged and were left in the patient's body.A new lead extension was implanted and the patient has stimulation covering the pain areas and is doing well post operatively.
Event or Problem Description
It was reported that during the procedure it was not possible to disconnect the temporary lead extension from the lead.A procedure in which surgical dissection of the lead extension was performed.It was additionally reported that due to the extended trial period, between the initial trial implant and the implantable pulse generator (ipg), a lot of fibrosis tissue developed around the electrode and extension bodies.It is not known why there was over a month between the implant dates.During the procedure it was discovered that the lead extension migrated, the physician used force to pull the lead extension causing it to break and leaving the prominent end of the lead extension implanted.Due to the force used by the physician to pull the lead extension out two contacts became dislodged and were left in the patients' body.A new lead extension was implanted and the patient has stimulation covering the pain areas and is doing well post operatively.It was additionally reported that the facility inadvertently provided the wrong device, unrelated to the spinal cord stimulator (scs), for analysis, therefore device analysis of the device associated with this issue can not be performed.

• Brand Name: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 16178925
• Report Number: 3006630150-2023-00058
• Device Sequence Number: 2661828
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: 08714729760559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 06/06/2023

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: 08/15/2024
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 7078850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 01/19/2023; 05/18/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 02/10/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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 Sex: Unknown