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); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported the patient had several non-device-related falls that resulted in inadequate stimulation.Although lead migration was confirmed, the physician assessed the inadequate stimulation was due to high impedances on the lead likely caused by the fall.Attempts to reprogram the device were unsuccessful, and the patient underwent a revision procedure where the lead and lead anchor were replaced.The patient did well post-operatively.

Manufacturer Narrative

Event date unknown.

Event Description

It was reported the patient had several non-device-related falls that resulted in inadequate stimulation.Although lead migration was confirmed, the physician assessed the inadequate stimulation was due to high impedances on the lead likely caused by the fall.Attempts to reprogram the device were unsuccessful, and the patient underwent a revision procedure where the lead and lead anchor were replaced.The patient did well post-operatively.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-lead fixation.Upn: m365sc43180, model: sc-4318, serial: unknown, batch: unknown.Microscopic and x-ray inspection by engineers of the returned lead sc-2317-70, serial: (b)(6) revealed that all cables were completely broken but unexposed two centimeters from the set screw mark of the clik x anchor at the bent/kinked location of the lead.This type of damage is the result of the lead being exposed to excessive mechanical force or movement.Additionally, visual inspection of the returned clik x anchor found both eyelets were torn; damage that likely occurred due to the lead migration.Therefore, the event of inadequate stimulation and high impedances was likely due to damage to the lead that resulted from the patient non-device-related falls and lead migration.

• 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: 13811982
• MDR Text Key: 287431892
• Report Number: 3006630150-2022-01095
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: 08714729861638
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/16/2022
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 5145657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2019
• 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