MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1200

Device Problems Unexpected Therapeutic Results (1631); Intermittent Energy Output (4025)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/05/2022

Event Type  Injury  

Event Description

It was reported the patient experienced a return of their pre-implant pain.The physician assessed stimulation had turned off without patient involvement.Attempts to reprogram the implantable pulse generator (ipg) and troubleshoot the patient's environment and potential causes of stimulation interference were unsuccessful.The patient underwent a procedure where the ipg was replaced and did well postoperatively.

Event Description

It was reported the patient experienced a return of their pre-implant pain.The physician assessed stimulation had turned off without patient involvement.Attempts to reprogram the implantable pulse generator (ipg) and troubleshoot the patient's environment and potential causes of stimulation interference were unsuccessful.The patient underwent a procedure where the ipg was replaced and did well postoperatively.

Manufacturer Narrative

The returned ipg passed the functional test, and the electrical test revealed normal device characteristics.Review of the system data log showed no signs of intermittent battery voltage.Stimulation was monitored on an oscilloscope and the output was consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current.Therefore, engineers we not able to definitively determine the cause of the reported event, as there were no problems detected with the returned device.

Manufacturer Narrative

The returned ipg passed the functional test, and the electrical test revealed normal device characteristics.Review of the system data log showed no signs of intermittent battery voltage.Stimulation was monitored on an oscilloscope and the output was consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current.However, the amount of ipg resets triggered by a magnet or electromagnetic interference suddenly increased while the ipg was implanted.The functionality of the component that detects the presence of a magnet reset was also tested, and exhibited normal device characteristics.To that end, a review of the instructions for use was completed and revealed that strong electromagnetic fields can potentially turn stimulation off, cause temporary umpredicatble changes to stimulation, or interfere with remote control communication.Therefore, engineers we not able to definitively determine the cause of the reported stimulation issues, as there were no problems detected with the returned device.

Event Description

It was reported the patient experienced a return of their pre-implant pain.The physician assessed stimulation had turned off without patient involvement.Attempts to reprogram the implantable pulse generator (ipg) and troubleshoot the patient's environment and potential causes of stimulation interference were unsuccessful.The patient underwent a procedure where the ipg was replaced and did well postoperatively.

• Brand Name: PRECISION MONTAGE MRI
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15663362
• MDR Text Key: 302328136
• Report Number: 3006630150-2022-05725
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2019
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 21148517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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