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

Model Number	SC-4319
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pressure Sore/Ulcer (2326); Weight Changes (2607)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-linear leads-mri, upn: m365sc2408560, model: sc-2408-56, serial: (b)(4), batch: 7071131.Product family: scs-linear leads-mri, upn: m365sc2408560, model: sc-2408-56, serial: (b)(4), batch: 7071150.Product family: scs-ipg-r-mri, upn: m365sc12000, model: sc-1200, serial: (b)(4), batch: 369748.
Event or Problem Description
It was reported that the patient had a clik anchor that had protruded and a bed sore was confirmed around that area.The patient underwent an explant procedure to remove the entire spinal cord stimulator system in consideration of the risk of infection.The physician stated that the patient had experienced weight loss and there is no relation between the implanted devices and this event.No infection was observed during the explant procedure.All explanted devices were discarded by the facility.

• Brand Name: CLIK X MRI
• 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: 11675870
• Report Number: 3006630150-2021-01600
• Device Sequence Number: 3014918
• Product Code: LGW
• UDI-Device Identifier: 08714729905325
• UDI-Public: 08714729905325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 02/24/2022
• Device Model Number: SC-4319
• Device Catalogue Number: SC-4319
• Device Lot Number: 25254149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/15/2021
• 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