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	Bacterial Infection (1735); Fluid Discharge (2686); No Code Available (3191)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-linear leads-mri, upn: (b)(4), model: sc-2408-56, serial: (b)(4), batch: 2000022942/5155872.Product family: scs-ipg-r-mri, upn: (b)(4), model: sc-1200, serial: (b)(4), batch: 363213.
Event or Problem Description
It was reported that the patient had an infection.Symptoms of small lump at the lead entry incision site and small oozing cyst at the anchor site were noted.It was not confirmed if the infection was device or procedure related.The patient was prescribed with antibiotics and underwent an explant procedure.All devices were removed and were not returned.

• 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: 10964332
• Report Number: 3006630150-2020-06054
• Device Sequence Number: 2322719
• Product Code: LGW
• UDI-Device Identifier: 08714729905325
• UDI-Public: 08714729905325
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 11/27/2020
• Device Model Number: SC-4319
• Device Catalogue Number: SC-4319
• Device Lot Number: 22986215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/08/2020
• 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
• Patient Age: 57 YR