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

Model Number SC-2317-50

Device Problems Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/13/2021

Event Type  malfunction  

Manufacturer Narrative

Exact date unknown, event occurred in (b)(6) 2021.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2317500, model: sc-2317-50, serial: (b)(4), batch: (b)(4).

Event Description

It was reported that the patients leads were fractured and had migrated which was confirmed in x-ray.It was also stated that the patient was experiencing inadequate stimulation and high impedance on both leads.

Event Description

It was reported that the patients leads were fractured and had migrated.It was also stated that the patient was experiencing inadequate stimulation and high impedance on both leads.Additional information was received that the patient underwent a lead replacement procedure and was doing well postoperatively with good coverage.The explanted device components were discarded by the medical facility and will not be returned.

• 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: 12665308
• MDR Text Key: 277390432
• Report Number: 3006630150-2021-05877
• 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,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2022
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 7071196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 77 KG