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

Model Number SC-4319

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pressure Sores (2326); Weight Changes (2607)

Event Date 03/18/2021

Event Type  Injury  

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 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
• Type of Device: 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11675870
• MDR Text Key: 245733618
• Report Number: 3006630150-2021-01600
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905325
• UDI-Public: 08714729905325
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention