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	Nausea (1970); Pain (1994); Vomiting (2144)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient was having pain at midline due to a loose anchor.The patient underwent a revision procedure wherein the anchor was reattached and the patient was doing well post-operatively.
Event or Problem Description
It was reported that the patient was having pain at midline due to a loose anchor.It was also reported that the patient was experiencing nausea and vomiting.The patient underwent a revision procedure wherein the anchor was reattached and ipg and leads together with the clik anchors were replaced.The patient was doing well post-operatively.Additional information was received that patient has post-operative pain.The physician suspected a dura puncture and administered a blood patch at the end of the revision surgery.
Event or Problem Description
It was reported that the patient was having pain at midline due to a loose anchor.It was also reported that the patient was experiencing nausea and vomiting.The patient underwent a revision procedure wherein the anchor was reattached and ipg and leads together with the clik anchors were replaced.The patient was doing well post-operatively.Additional information was received that patient has post-operative pain.The physician suspected a dura puncture and administered a blood patch at the end of the revision surgery.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the even: product family: scs-linear leads-mri, upn: m365sc2408740, model: sc-2408-74, serial: (b)(6), batch: 5141621/5147220.Sc-2408-74 (sn: (b)(6).The returned leads were analyzed, and the lead was cleanly cut during the explant procedure.The damage was a result of a typical explant procedure, and it was not considered a failure.X-ray inspection found no other anomalies on the leads.However, a labelling review found that the reported event was a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation.Therefore, an inherent risk of device was detected.Sc-4319 (ln: 23711402).The returned clik anchor was analyzed, and the complaint was confirmed.One of the anchors was torn apart.Hence, the probable cause was traced to a component failure.

• 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
• 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: 11478199
• Report Number: 3006630150-2021-00946
• Device Sequence Number: 3281053
• Product Code: LGW
• UDI-Device Identifier: 08714729905325
• UDI-Public: 08714729905325
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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: 04/29/2021
• Device Model Number: SC-4319
• Device Catalogue Number: SC-4319
• Device Lot Number: 23711402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 06/01/2022; 07/12/2022
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 06/17/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 79 KG