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

Model Number 3189

Device Problem Low impedance (2285)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

The event date is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-12806.It was reported the patients leads displayed low impedance resulting in ineffective and uncomfortable simulation.Surgical intervention was undertaken wherein the leads were explanted and replaced with a single lead.Surgical intervention addressed the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively 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: 11602079
• MDR Text Key: 243342826
• Report Number: 1627487-2021-12805
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 7726115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3189, PERCUTANEOUS LEAD; MODEL: 3189, PERCUTANEOUS LEAD
• Patient Outcome(s): Other
• Patient Weight: 77