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 Pain (1994); Inadequate Pain Relief (2388)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred 4 weeks ago from the appointment date (b)(6) 2021.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2317700, model: sc-2317-70, serial: (b)(4), batch: 7073488,.

Event Description

It was reported that the patient could no longer feel the stimulation, despite reprogramming attempt.Patients leads were completely out except for three functioning contacts on left lead.The patient was able to regain coverage utilizing the functional contacts with a low stimulation running, as patient would get a sharp pain when turned up higher.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Event Description

It was reported that the patient could no longer feel the stimulation, despite reprogramming attempt.Patients leads were completely out except for three functioning contacts on left lead.The patient was able to regain coverage utilizing the functional contacts with a low stimulation running, as patient would get a sharp pain when turned up higher.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2317-70 sn: (b)(6).The returned device was analyzed and the reported event was confirmed.Based on a review of all available information contacts on the patient's lead were out.All cables were fractured at the click site, about 20.5 centimeters from the distal end.When excessive mechanical or tensile force was exerted onto the lead, the lead got kinked after it exits the clik anchor resulting in the cable fractures, which caused the reported patients experience.

• 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: 12648215
• MDR Text Key: 276900481
• Report Number: 3006630150-2021-05831
• 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: 12/30/2021

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: 06/05/2022
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7072692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2020
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 97 KG