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

Model Number 3186

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problems Irritation (1941); Device Overstimulation of Tissue (1991); Cramp(s) (2193)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Further information was requested but 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 1627487-2020-00714.It was reported that during the patient¿s scs trial they were experiencing neurological side effects which included cramping in the patient¿s left arm and fingers, as well as what the patient described as a rubber band around their fingers.When stimulation was turned on, the patient would get a shocking sensation.Diagnostics revealed low impedance.A cat scan determined the lead was touching the spinal cord.The patient was transferred to a hospital to undergo an mri and further evaluations.

Manufacturer Narrative

The serial number, lot number, expiration date, udi, physician¿s name, and device manufacture date have been obtained.

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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, 60CM LENGTH
• Type of Device: SCS 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: 9625064
• MDR Text Key: 176209003
• Report Number: 1627487-2020-00715
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 7247377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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 LEAD
• Patient Outcome(s): Hospitalization; Other