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

Model Number 3189

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

Patient Problems Pulmonary Embolism (1498); Death (1802); Paraplegia (2448)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

The reported event cannot be analyzed via laboratory testing.Manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr.Report#: 1627487-2018-06920.It was reported ((b)(6)) the patient experienced loss of sensation in their left leg following an scs implant procedure on (b)(6) 2018.Ct scan revealed some air/fluid in the subarachnoid space.Subsequently the patient regained sensation and mobility in the leg.The physician stated the nerve fibers may have been irritated while gaining access to the epidural space during the implant and the patient's symptoms were improving.No further action taken at the time as the patient¿s symptoms were improving.However, the patient passed away on (b)(6) 2018 due to deep vein thrombosis leading to a pulmonary embolism.The patient had co morbidities and that the death was a result of these co morbidities.The reason stated was the time spent on the table during the procedure.Reportedly the issue was not related to the device.

• Brand Name: OCTRODE LEAD KIT, 90CM 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: taruna sharma ; 6901 preston road; plano, TX 75024 ; 9725269635
• MDR Report Key: 7722736
• MDR Text Key: 115112427
• Report Number: 1627487-2018-06922
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• 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
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Model Number: 3189
• Device Lot Number: 6102165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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: MODEL 3772, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 53 YR