MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS TRIAL LEAD

Model Number 3086

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

Patient Problems Pain (1994); Vomiting (2144); Loss of consciousness (2418)

Event Date 07/26/2021

Event Type  Injury  

Event Description

Manufacturer related report number: 3006705815-2021-03984.It was reported the patient was implanted with trial leads on (b)(6) 2021, on 26 july the patient performed chiropractic manipulation to align vertebrae.Following the alignment the patient experienced excruciating pain, was sweating, took pain medication and turned stimulation strength down.After a few hours the patient vomited and lost consciousness.Paramedics were called to assist the patient and the patient later died on (b)(6) 2021.

Manufacturer Narrative

A patient death was reported to abbott.The cause of the patient's death is unknown.It was determined the patient was implanted with trial leads, and a chiropractic manipulation to align vertebrae was performed.Following the alignment the patient experienced excruciating pain, sweating, and therefore took pain medication.The stimulation strength was turned down.After a few hours the patient vomited and lost consciousness.Paramedics were called to assist the patient and the patient later died.No scs system complaints were reported nor were implanted products returned for analysis.All event information pertaining to this device has been reviewed and no product investigation is necessary at this time as the circumstances of the event have not been attributed to the implanted system.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS TRIAL LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 12321100
• MDR Text Key: 266488315
• Report Number: 3006705815-2021-03983
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401555
• UDI-Public: 05414734401555
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: A000109605
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3086 SCS TRIAL LEAD; 3086 SCS TRIAL LEAD
• Patient Outcome(s): Death; Other
• Patient Weight: 86