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 Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Date 05/15/2015

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report #: 1627487-2015-07288.It was reported the patient experienced sharp and radiating pain following the trial procedure in the cervical area on (b)(6) 2015.A grip test was taken and the patient could not grab with his left hand.In turn, the patient was monitored and given pain medication, but it could not provide resolution.The patient had stimulation in his pain areas, but the stimulation made the pain worse.As a result, both leads were pulled.After the procedure, it was reported the pain had slightly improved and the patient was able to grip better with his left hand.On (b)(6) 2015, the patient went to the emergency room due to continuous pain and was given medrol dosepack and the pain had gone away as of (b)(6) 2015.However, the patient was still having issues.On (b)(6) 2015, the patient was seen by the nurse practitioner and given another medrol dosepack.An mri was done but the doctor could not see any issues that could be causing the pain.The patient was sent to his pain management doctor.

Manufacturer Narrative

Udi (di): (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.

• 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: 4825924
• MDR Text Key: 5843769
• Report Number: 1627487-2015-07287
• 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
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 3086
• Device Lot Number: 4997077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2015
• 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
• Treatment: MODEL: 1192 (X2), SCS ANCHORS
• Patient Outcome(s): Other
• Patient Age: 60 YR