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

Model Number 3186

Device Problem Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete event, patient and device information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related mfg report: 1627487-2020-23224.It was reported that the patient experienced a decrease in therapy due to issues with their leads.The patient's leads were then explanted.

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete event information.Further information was requested but not received.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: 10338515
• MDR Text Key: 200802768
• Report Number: 1627487-2020-23326
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734406130
• UDI-Public: 05414734406130
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 4694977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other