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 Unspecified Infection (1930); Skin Erosion (2075)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Manufacturer report reference number: 1627487-2020-32584.It was reported that the patient experienced erosion.The patient's right lead is protruding through the skin.As a result, the patient may undergo surgical intervention to address the issue.Note: it is unknown to the manufacturer which lead is protruding through the skin, therefore both leads are being reported on.

Event Description

Manufacturer report reference number: 3006705815-2020-33072.Further information received that the patient developed an infection and underwent surgical intervention in which the system was explanted.The infection is resolved.

Manufacturer Narrative

Correction d6 - implant date should be (b)(6) 2020 instead of (b)(6) 2019.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: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10686823
• MDR Text Key: 211629833
• Report Number: 1627487-2020-32586
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

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: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 6798699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 11/20/2020; 12/28/2020
• Supplement Dates FDA Received: 12/04/2020; 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3189, SCS LEAD; MODEL 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 68