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

Model Number 3186

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain patient weight, but it was not received.The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 3006705815-2019-05098.It was reported that the patient experienced ineffective stimulation due to the system auto-reducing.X-rays were taken which confirmed lead fracture and diagnostics showed high impedances on multiple contacts.In turn, surgical intervention was undertaken on (b)(6) 2019 wherein the leads were explanted and replaced.Post-operatively, stimulation therapy was restored.

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: SCS PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9535929
• MDR Text Key: 173228831
• Report Number: 1627487-2019-14374
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2019
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 5991567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS PERCUTANEOUS LEAD
• Patient Outcome(s): Other
• Patient Age: 43 YR