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); Pain (1994); Staphylococcus Aureus (2058); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-paddle leads-mri, upn: (b)(4), model: sc-8416-70, serial: (b)(4), batch: 7013078.

Event Description

It was reported that the patient developed an infection and will undergo spinal cord stimulator (scs) explant procedure.

Event Description

It was reported that the patient developed an infection and will undergo future explant procedure.Additional information was received that the non device related infection was located at the ipg pocket site incision.Symptoms include drainage, non closure, and pain at pocket site.The patient was initially placed on iv antibiotics, then switched to oral antibiotics.Cultures were taken and the result revealed staphylococcus aureus and oxacillin susceptible staphylococcus aureus (ossa).The patient underwent a full system explant procedure and was doing well postoperatively.The explanted ipg and paddle lead were discarded by the medical facility.

• 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: 10448255
• MDR Text Key: 204199031
• Report Number: 3006630150-2020-03621
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2021
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 361396
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR