MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD

Model Number MN20450-50A

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

Patient Problems Purulent Discharge (1812); Pain (1994); Post Operative Wound Infection (2446)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-49311, related manufacturer reference number: 1627487-2020-49312.It was reported that the patient experienced cold shivers and pain at the implant site.Physician noted pus and the implant site was warm, imaging revealed small pus pockets over the entire spine.As such, surgical intervention took place on (b)(6) 2020 wherein the entire system was explanted to address the issue.Subsequently, on (b)(6) 2020 patient underwent a laminectomy to drain the abscess.Patient was treated with antibiotics.Reportedly, the wound has healed and issue resolved.

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Manufacturer Narrative

B3 date of event is being corrected from (b)(6) 2020 to (b)(6) 2020.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11095194
• MDR Text Key: 224317882
• Report Number: 1627487-2020-49313
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2021

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: No Information
• Device Expiration Date: 06/08/2022
• Device Model Number: MN20450-50A
• Device Lot Number: 7528494
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 06/12/2021
• Supplement Dates FDA Received: 01/20/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG IPG, MODEL 3664.; DRG LEAD, MODEL MN20450-50A.; DRG IPG, MODEL 3664; DRG LEAD, MODEL MN20450-50A
• Patient Outcome(s): Other