MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 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); Ambulation Difficulties (2544)

Event Date 03/12/2015

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report #1627487-2015-12170.It was reported, the patient underwent an scs trial procedure on (b)(6) 2015, during the procedure the physician was unable to place a second lead due to the patient's anatomy.During that night the patient reportedly experienced pain that was not relieved by the stimulation and the patient took a pain pill.The following morning the patient stated he could not feel or move his legs, although, he could move his feet.The patient went to the er and it was determined there was a spinal hematoma.The patient's lead was explanted and the hematoma was removed on (b)(6) 2015.The patient has been transferred to a rehabilitation facility and he is currently able to feel his right foot and is beginning to move his left leg.

Event Description

The patient's wife reported the patient was discharged from the rehabilitation facility and is receiving daily home care and physical therapy in the home three times a week.The patient is wheelchair bound, has feeling in both feet but has no function is his right leg.The patient is continuing physical therapy.

Manufacturer Narrative

(b)(4).Sjm 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.

Manufacturer Narrative

Sjm 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.

• Brand Name: OCTRODE TRIAL 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
• MDR Report Key: 4674567
• MDR Text Key: 5624444
• Report Number: 1627487-2015-12169
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2015

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: 12/28/2016
• Device Model Number: 3086
• Device Lot Number: 4899412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR