MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD

Model Number 3186

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

It was reported the lead had fractured.In turn, the lead was explanted and replaced to address the issue.

Manufacturer Narrative

The report event of lead fracture/high impedance was confirmed.Analysis of the return lead found a kink/fracture on the outer tubing where all internal wires were broken.The fracture was consistent with an overstress condition or sudden event the lead may have been subjected to while still in vivo.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12441200
• MDR Text Key: 270364292
• Report Number: 1627487-2021-16887
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 7594986
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR