MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2366-30
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Scar Tissue (2060); Inadequate Pain Relief (2388)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2366500, model: sc-2366-50, serial: (b)(4), batch: 14914926.Product family: scs-ipg-r, upn: m365sc1110020, model: sc-1110-02, serial: (b)(4), batch: 15381175.Product family: scs-linear fixation, upn: m365sc43160, model: sc-4316, serial: na, batch: 15478273.
Event or Problem Description
It was reported the patient experienced inadequate stimulation.The physician assessed the event was due to high impedances cause by scar tissue that had formed around several of the lead contacts.Reprogramming attempts were unsuccessful, and the patient underwent an explant procedure to remove all implanted devices and will be implanted again at a later date.Patient was stable post-operatively.
Event or Problem Description
It was reported the patient experienced inadequate stimulation.The physician assessed the event was due to high impedances cause by scar tissue that had formed around several of the lead contacts.Reprogramming attempts were unsuccessful, and the patient underwent an explant procedure to remove all implanted devices and will be implanted again at a later date.Patient was stable post-operatively.
Additional Manufacturer Narrative
Based on all the available information, engineers concluded that the event of inadequate stimulation due to high impedances caused by scar tissue was confirmed with device analysis.Visual inspection of the sc-2366-50 serial: (b)(6) revealed the lead was cleanly cut in the middle portion and approximately 20 centimeters in length was not returned.Other than the clean cut, device analysis revealed no anomalies with the lead; however, scar tissue was found on the distal end of the lead.Per the device instructions for use (ifu) undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes is a known risk of being implanted with the device.Visual and x-ray inspection of the sc-2366-30 serial: (b)(6), sc-1110-02 serial: (b)(6), and sc-4316 lot: 15478273 revealed no anomalies.

• Brand Name: LINEAR 3-6
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 12071141
• Report Number: 3006630150-2021-03235
• Device Sequence Number: 4154428
• Product Code: LGW
• UDI-Device Identifier: 08714729789659
• UDI-Public: 08714729789659
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: Lay User/Patient
• Device Expiration Date: 04/18/2014
• Device Model Number: SC-2366-30
• Device Catalogue Number: SC-2366-30
• Device Lot Number: 15160524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention