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

Model Number SC-2317-70

Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

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: m365sc2317700.Model: sc-2317-70.Serial: (b)(4).Batch: 5174909.

Event Description

It was reported that the patient no longer felt paresthesia due to high impedances on the leads despite a reprogramming attempt.Fracture on the lead was also noted.

Event Description

It was reported that the patient no longer felt paresthesia due to high impedances on the leads despite a reprogramming attempt.Fracture on the lead was also noted.Additional information was received that the patient was having difficulty charging the ipg.The patient underwent a revision procedure wherein the ipg and leads were replaced.The patient was doing well postoperatively, and the explanted devices were disposed.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2218700.Model: sc-2218-70.Serial: (b)(6).Batch: 7077094.

• 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: 15663835
• MDR Text Key: 303443349
• Report Number: 3006630150-2022-05728
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: 08714729861638
• 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,Followup
• Report Date: 03/07/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2021
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 5121521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• 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: 73 YR
• Patient Sex: Female