MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; SPINAL CORD STIMULATOR

Model Number SC-8416-70

Device Problems High impedance (1291); Material Separation (1562)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/01/2018

Event Type  Injury  

Event Description

A report was received that the patient was experiencing loss of stimulation due to high impedances.X¿ray was taken and it was confirmed that the lead had pulled out of the cervical epidural space.The patient underwent a lead replacement procedure.

Manufacturer Narrative

Correction to initial mdr should have been (b)(6) 2018.Sc-8416-70 (b)(4) device evaluation indicated that visual inspection revealed that tails of the paddle lead were cleanly cut at 54 cm from proximal ends and the paddle was not returned.X-ray inspection found no cable breakage on the returned tails of the lead.The clean-cut damage was a result of a typical explant procedure and it was not considered a failure.The clik x mri anchor was not meant to be used with an sc-8416-70 paddle lead.Sc-4316 device evaluation indicated that visual inspection revealed that the clik anchors had torn overmold and the set screws were missing.Clik x mri anchors were not meant to be used with sc-8416-70 paddle leads.

Event Description

A report was received that the patient was experiencing loss of stimulation due to high impedances.An x-ray was taken and it was confirmed that the leads had pulled out of the cervical epidural space.The patient underwent a lead replacement procedure.During the procedure the physician noted that the paddle lead had pulled through the clik anchor and sheared off all but six contacts as well as sheared off part of the anchor itself.Most of the contacts were retrieved however three were left in the subcutaneous lead track and deemed not to be problematic.There will be no further course of action regarding the contacts left inside the patient.The patient is doing well postoperatively.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-4319 lot#: 20933581 description: clik x mri anchor.

Event Description

A report was received that the patient was experiencing loss of stimulation due to high impedances.An x-ray was taken and it was confirmed that the leads had pulled out of the cervical epidural space.The patient underwent a lead replacement procedure.During the procedure the physician noted that the paddle lead had pulled through the clik anchor and sheared off all but six contacts as well as sheared off part of the anchor itself.Most of the contacts were retrieved however three were left in the subcutaneous lead track and deemed not to be problematic.There will be no further course of action regarding the contacts left inside the patient.The patient is doing well postoperatively.

• Brand Name: PRECISION MONTAGE MRI
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7379799
• MDR Text Key: 103772127
• Report Number: 3006630150-2018-01128
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951131
• UDI-Public: 08714729951131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2018

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: 10/23/2019
• Device Model Number: SC-8416-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 04/25/2018
• Supplement Dates FDA Received: 04/05/2018; 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• 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: 53 YR