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

Model Number SC-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058); Fluid Discharge (2686); No Code Available (3191)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

Model number / catalog number: sc-8416-50, serial number: (b)(4), batch/lot number: 7033006, model/catalog description: artisan mri paddle lead 50 cm.The explanted devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the ipg and lead revealed that no anomalies or deviations potentially relate to the event occurred during manufacturing.A review of the sterilization documentation for the ipg and lead was found to be satisfactory.

Event Description

A report was received that the patient had a possible infection.Drainage was noted at the ipg site.The physician believed that the infection was not device nor procedure related and the cause of infection was due to patients immune system.The patient was placed on antibiotics and underwent an explant procedure.

Event Description

A report was received that the patient had a possible infection.Drainage was noted at the ipg site.The physician believed that the infection was not device nor procedure related and the cause of infection was due to patients immune system.The patient was placed on antibiotics and underwent an explant procedure.

• 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
• MDR Report Key: 9067715
• MDR Text Key: 158808567
• Report Number: 3006630150-2019-05053
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2021
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 362598
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/15/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR