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

Model Number SC-2317-70

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/14/2022

Event Type  Injury  

Event Description

It was reported that the patient had inadequate stimulation due to high impedances on the lead.Pain was poorly controlled despite reprogramming.The patient underwent a lead replacement procedure and was doing well postoperatively.

Manufacturer Narrative

Exact date unknown, event occurred a month from the date the manufacturer became aware.Additional suspect medical device component involved in the event: product family: scs-linear leads: upn: m365sc2317700.Model: sc-2317-70.Serial: (b)(4).Batch: 7076432.

Manufacturer Narrative

Sc-2317-70, (sn (b)(6)).The returned lead was analyzed and no anomalies were identified on the lead aside from the clean-cut.The lead was damaged and cut into two pieces as a result of a typical explant procedure and is not considered a failure.With all the available information, boston scientific concludes that the complaint of impedance anomaly could not be confirmed.

Event Description

It was reported that the patient had inadequate stimulation due to high impedances on the lead.Pain was poorly controlled despite reprogramming.The patient underwent a lead replacement procedure and was doing well postoperatively.

• 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: 15709707
• MDR Text Key: 302790888
• Report Number: 3006630150-2022-05886
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/20/2023
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7076417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 89 KG