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

Model Number 3086

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

Patient Problems Hematoma (1884); Neurological Deficit/Dysfunction (1982); Paresis (1998)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.St.Jude medical 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.Sjm defers to the patient's physician regarding medical history.

Event Description

It was reported the patient underwent a trial procedure on (b)(6) 2017.The patient experienced a zapping sensation and collapsed and was taken to the er.In addition the patient experienced a loss of motor and sensory function from the chest down on (b)(6) 2017.The trial lead was removed and an mri was done.An epidural hematoma on t1-11 was discovered and a decompression was performed.On (b)(6) 2017 the patient had regained sensation and mobility in the left leg and was beginning to be able to move the right leg.There were no issue or difficulties during the implant of the trial lead and the patient was doing well on (b)(6) 2017.The patient was discharged and is ambulating.The patient is receiving physical therapy.

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. .

Event Description

The following information are allegations from the patient: additional information received revealed the patient was released from a rehabilitation facility on (b)(6) 2017.The patient continues to experience gait abnormality and weakness in legs, as well as abdominal pain and painful symptoms in his lower extremities.Steroid injections have been administered and have only provided temporary relief.The hematoma removal surgery has left the patient in excruciating pain and the patient continues to suffer from limitations associated from the surgical procedure.Also, the patient has been suffering from painful neck and back conditions and chills at the surgery site and across his back.Lastly, the patient has been experiencing loss of bladder function, incontinence, and bowel issues since the surgical procedure as well.And at times when the patient stands he experiences shaking and jerking motions.No further information has been provided.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: tanja hoffman ; 6901 preston road; plano, TX 75024 ; 9723098520
• MDR Report Key: 6869018
• MDR Text Key: 86319914
• Report Number: 3006705815-2017-01202
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2021

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: 06/20/2019
• Device Model Number: 3086
• Device Lot Number: A000041705
• Other Device ID Number: 05414734401555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 10/14/2020; 01/29/2021
• Supplement Dates FDA Received: 11/12/2020; 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR