MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION CX; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2317-50

Device Problems High impedance (1291); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-linear leads upn: m365sc2317500 model: sc-2317-50 serial: (b)(6) batch: 7078499 sc-2317-50 (sn (b)(6) the returned lead was analyzed and visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.There were no exposed cables at the fracture location.The lead became kinked after it exited the clik x anchor resulting in the reported complaint.With all the available information, boston scientific concludes that the allegation of high impedances was confirmed.It appears that the lead was exposed to excessive mechanical force or movement when it migrated, causing the cable fractures right at the anchor point.Sc-2317-50 (sn (b)(6) the returned lead was analyzed and visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.There were no exposed cables at the fracture location.The lead became kinked after it exited the clik x anchor resulting in the reported complaint.With all the available information, boston scientific concludes that the allegation of high impedances was confirmed.It appears that the lead was exposed to excessive mechanical force or movement when it migrated, causing the cable fractures right at the anchor point.

Event Description

It was reported that the leads had high impedances and lead sync taken showed migration.The patient underwent a lead explant procedure.

• Brand Name: INFINION CX
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18962042
• MDR Text Key: 338388202
• Report Number: 3006630150-2024-01705
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: 08714729861614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2023
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 7073736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Race: White