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

Model Number 3186

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/23/2014

Event Type  Injury  

Event Description

It was reported the pt (b)(6) lost stimulation.In turn, the pt underwent surgical intervention.During the procedure the physician noted one of the pt's trial leads appeared to have an impression on the outer insulation and the lead was no longer needed.As a result, the physician explanted the trial lead which resolved the issue.

Manufacturer Narrative

Results: it was found that the returned lead had a kink in the outer tubing with all internal wires broken.It was concluded that the fracture in the lead was consistent with stress the lead was subjected to at the distal end of the swift-lock anchor.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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 4201971
• MDR Text Key: 5151008
• Report Number: 1627487-2014-25649
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: 3186
• Device Lot Number: 4075000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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
• Treatment: IMPLANT DATE:; SCS ANCHOR, MODEL 1192,
• Patient Outcome(s): Other