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); Unexpected Therapeutic Results (1631)

Patient Problems Anxiety (2328); Inadequate Pain Relief (2388)

Event Date 06/02/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced inadequate stimulation due to high impedances displayed on the spinal cord stimulation (scs) lead.The patients device was reprogrammed, however, the reported issue persisted.The patient underwent a lead revision procedure where the lead was explanted and replaced.The patient is doing well postoperatively.

Event Description

It was reported that the patient experienced inadequate stimulation due to high impedances displayed on the spinal cord stimulation (scs) lead.The patient's device was reprogrammed, however, the reported issue persisted.The patient underwent a lead revision procedure where the lead was explanted and replaced.The patient is doing well postoperatively.

Manufacturer Narrative

The returned lead was analyzed and engineers found that multiple cables were fractured two centimeters from the set screw mark of the anchor.The engineers have concluded that the reported event of lead damage, resulting in high impendence's, inadequate stimulation, and anxiety are a known inherent risk with implanting a pulse generator as part of a system to deliver spinal cord stimulation.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15196620
• MDR Text Key: 297570384
• Report Number: 3006630150-2022-03944
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: 08714729861614
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/10/2023
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 7074289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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