MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH; PERCUTANEOUS LEAD

Model Number 3189

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

Patient Problems Seroma (2069); Post Operative Wound Infection (2446)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this incident, attempts were made to obtain complete customer information.

Event Description

Related manufacturer reference number: 1627487-2021-13607.Related manufacturer reference number: 1627487-2021-13608.It was reported that the patient was experiencing an infection, seroma, and keloid scarring, which were causing discomfort at the implant sites.As a result, the patient's system was explanted and the patient is recovering.

Manufacturer Narrative

Correction, d6b: date of explant provided.

Manufacturer Narrative

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: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11740663
• MDR Text Key: 247909540
• Report Number: 1627487-2021-13610
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 7590506
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3189; 3772
• Patient Outcome(s): Other