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 Problems Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 03/17/2017

Event Type  Injury  

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.

Event Description

Device 3 of 3.Reference mfr report: 1627487-2017-04712.Reference mfr report: 1627487-2017-04713.It was reported ((b)(6)) the patient experienced a significant spasm while in x-ray.The patient was fully oriented upon examination and scs system diagnostics were normal.The patient alleged receiving overstimulation sensations down both legs with pain shooting up his upper back and arm.The patient also described feeling a warm sensation at ipg site and pain at the lead sites which occurs with stimulation turned on and off.A representative met with the patient for diagnostic testing.All contacts were within normal impedance range and the system was operating as intended.X-rays confirmed the leads were still in proper position to capture targeted pain areas.Reprogramming was unable to resolve the issue.The patient underwent surgical intervention where the entire scs system was removed.

• 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: 6827327
• MDR Text Key: 83878853
• Report Number: 1627487-2017-04714
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 3186
• Device Lot Number: 5128330
• Other Device ID Number: 05414734401708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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