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

Model Number SC-8416-70

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

Patient Problems Bacterial Infection (1735); Pain (1994); Staphylococcus Aureus (2058); Fluid Discharge (2686); No Code Available (3191)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri, upn: (b)(4), model: sc-1200, serial: (b)(4), batch: 369048.

Event Description

It was reported that the patient had an infection at the upper midline incision site.Symptoms of infection were pain, redness and drainage at the site.The patient was brought to the operating room (or) and it was determined that the patients infection was deep.The physician believed that the infection was not device related, however, it was procedure related.The patient was prescribed antibiotics.The physician decided to explant all device components and irrigated both incisions.The explanted devices were discarded.

• Brand Name: ARTISAN 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; road 698, lot no. 12; dorado PR 00646 -260; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10366601
• MDR Text Key: 201667570
• Report Number: 3006630150-2020-03239
• 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: P030017
• 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
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2022
• Device Model Number: SC-8416-70
• Device Catalogue Number: SC-8416-70
• Device Lot Number: 7070590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• 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: 46 YR