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 Wound Dehiscence (1154); Unspecified Infection (1930); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred two weeks ago from date manufacturer was made aware.

Event Description

It was reported that the patient had an infection at the ipg site and the incision had started to split open.The patient was placed on antibiotics.The physician believed that the infection was not device or procedure related as the patient had history of infections.The patient underwent a revision procedure wherein the physician opened the incision over the battery flushed and re-closed the incision.

Event Description

It was reported that the patient had an infection at the ipg site and the incision had started to split open.The patient was placed on antibiotics.The physician believed that the infection was not device or procedure related as the patient had history of infections.The patient underwent a revision procedure wherein the physician opened the incision over the battery flushed and re-closed the incision.Additional information was received that the patient was doing well postoperatively and there was no sign of infection at this time.

• 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: 11116685
• MDR Text Key: 225059546
• Report Number: 3006630150-2020-06551
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 367048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR