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 06/09/2022

Event Type  Injury  

Manufacturer Narrative

Exact date unknown: event occurred two weeks ago from date manufacturer was made aware.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2317700.Model: sc-2317-70.Serial: 7076319.Batch: 7076319.

Event Description

It was reported that the patient experienced inadequate and loss of stimulation despite reprogramming attempt.It was noted that the patients lead had high impedances.The patient underwent a revision procedure where in the leads were removed and a new paddle was implanted.

Manufacturer Narrative

Sc-2317-70 (sn: (b)(6).The returned leads were analyzed and visual (microscope) and x-ray inspection of the leads revealed that multiple cables were completely broken at the bent/kinked location of the leads.The bent/kinked location was 2 cm from the set screw mark of the clik x anchor.There were no exposed cables at the fractured location.The leads got kinked after it exited the clik x anchor resulting in the reported complaint.With all the available information, boston scientific concludes that the allegation of high impedance has been confirmed.It appeared that the leads were exposed to excessive mechanical force or movement causing the cable fractures right at the anchor point.

Event Description

It was reported that the patient experienced inadequate and loss of stimulation despite reprogramming attempt.It was noted that the patients lead had high impedances.The patient underwent a revision procedure wherein the leads were removed and a new paddle was implanted.Additional information was received that the patient 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15198512
• MDR Text Key: 297687436
• Report Number: 3006630150-2022-03947
• 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: 09/09/2022

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: 09/14/2023
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7076279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• 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: 39 YR
• Patient Sex: Female