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

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Paralysis (1997)

Event Date 09/06/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient was experiencing uncomfortable sensation.The patient also reported having developed weakness in both legs and urinary incontinence.In turn, surgical intervention was undertaken wherein the entire system as explanted to address the issue.

Event Description

Additional information received indicated the patient suffered temporary paralysis following the event.This has since resolved following physical therapy.The patient still does not have complete feeling in the buttocks.

Manufacturer Narrative

As received, the octrode lead passed all electrical testing.No root cause was identified for the reported event.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10610811
• MDR Text Key: 209327535
• Report Number: 1627487-2020-31982
• 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,Followup
• Report Date: 01/04/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2020
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 6329658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/11/2020; 12/28/2020
• Supplement Dates FDA Received: 12/02/2020; 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other