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

Model Number 3186

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

Patient Problem Muscle Spasm(s) (1966)

Event Type  Injury  

Manufacturer Narrative

The 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2017-07514.It was reported the patient presented to the emergency room due to leg spasms.The patient has two systems, an scs and a drg system.The leg spasms were present regardless of drg stimulation.The scs system was also turned off; however, it was not confirmed if spasms were still present after scs therapy was off.Follow-up identified surgical intervention is planned to address the issue.

Event Description

Device 1 of 2, reference mfr.Report: 1627487-2017-07514.Follow-up identified the patient underwent surgical intervention on (b)(6) 2017 during which the drg lead was revised (reference mfr.Report: 3008829311-2017-00826).At this time, it is unknown if any intervention was undertaken on the scs leads during the procedure.

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2017-07514.Follow-up identified there was no further intervention performed on the scs leads.

• 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
• MDR Report Key: 7051131
• MDR Text Key: 92714842
• Report Number: 1627487-2017-07513
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 3186
• Device Lot Number: 4287207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2013
• 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): Other