MAUDE Adverse Event Report: ST JUDE MEDICAL NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3086

Device Problem Failure to Advance (2524)

Patient Problem Pain (1994)

Event Date 04/22/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent a trial procedure.During the procedure, the doctor took 45 minutes to make attempts to access the cervical and thoracic areas.The doctor was eventually able to access the thoracic area but struggled to do so.The patient experienced pain once the lead was advanced.As a result, the procedure was abandoned.Post-op, the patient was assessed and no loss of function or long term pain were present.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: OCTRODE
• 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
• Manufacturer Contact: ahmad johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3820010
• MDR Text Key: 21527085
• Report Number: 1627487-2014-05343
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/22/2014

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 Model Number: 3086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: No
• 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