MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION

Model Number 3346

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

Patient Problem Unspecified Infection (1930)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 1627487-2020-33455, 1627487-2020-33456, 1627487-2020-33457, 1627487-2020-33458, 1627487-2020-33460, 3006705815-2020-32551.It was reported that the patient was diagnosed with an infection at an unknown site.In turn, surgical intervention may take place at a later date to address the issue.No additional information is known at this time.

Event Description

Additional information received indicated the patient underwent surgical intervention wherein the entire system was explanted to address the issue.

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.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 60CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10807059
• MDR Text Key: 215264889
• Report Number: 1627487-2020-33459
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402309
• UDI-Public: 05414734402309
• Combination Product (y/n): N
• PMA/PMN Number: K032751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 4854211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION; SCS IPG; SCS LEAD X4; SCS EXTENSION; SCS IPG; SCS LEAD X4
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 73