MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD

Model Number 3186

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of event is estimated.Further information was requested but not received.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient lost therapy due to high impedances.Reportedly, the lead is fractured.As such, surgical intervention may take place at a later date to address the issue.

Event Description

Related manufacturer reference number: 1627487-2020-31763 additional information received indicated surgical intervention took place on (b)(6) 2020 wherein the leads were explanted and replaced with new leads addressing the issue.Reportedly, therapy was confirmed post operatively.New information revealed that patient had 2 leads.

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 incident could not be conclusively determined.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10347046
• MDR Text Key: 201358379
• Report Number: 1627487-2020-23423
• Device Sequence Number: 1
• Product Code: LGW
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD, MODEL 3186
• Patient Outcome(s): Other