MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE X 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-8352-50

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

Patient Problems Pain (1994); Staphylococcus Aureus (2058); No Code Available (3191)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred in early august.

Event Description

It was reported that the patient had a methicillin-resistant staphylococcus aureus (mrsa) infection.It was also noted that the patient was experiencing increased pain and had to go to the emergency room (er) three times before the patient was diagnosed with infection.The physician believed that the infection was not device related.The patient was prescribed with antibiotics and underwent an explant procedure.The explanted device was not returned.

Event Description

It was reported that the patients lead was infected and was explanted.The physician assessed the infection was not device related.The patient was prescribed with antibiotics prior to the explant procedure and pain reliever thereafter.The explanted lead will not be returned.Additional information was received that the infection was not procedure related.

• Brand Name: COVEREDGE X 32
• 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: 10760369
• MDR Text Key: 213844696
• Report Number: 3006630150-2020-05258
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832683
• UDI-Public: 08714729832683
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2022
• Device Model Number: SC-8352-50
• Device Catalogue Number: SC-8352-50
• Device Lot Number: 7070028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 73