MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; PERCUTANEOUS LEAD

Model Number 3189

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Device Overstimulation of Tissue (1991); Seizures (2063)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number 1627487-2020-23834.It was reported patient experienced a seizure and uncomfortable stimulation during a reprogramming session.Reportedly, patient has a history of seizures.Patient was treated with ativan and oxygen to no avail.Patient was then sedated, intubated and hospitalized for two days.Effective therapy was successfully restored.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10404913
• MDR Text Key: 202871991
• Report Number: 1627487-2020-23833
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 7054944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3189, SCS LEAD
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 42 YR
• Patient Weight: 100