MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16C LEAD, 60 CM; SCS LEAD

Model Number 3214

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 12/11/2014

Event Type  Injury  

Event Description

It was reported the patient is experiencing stimulation in the incorrect location.Reprogramming was unable to resolve the issue.X-rays were taken and indicated the lead had migrated.Surgical intervention may take place at a later date to address the issue.

Event Description

Follow-up information indicated surgical intervention was undertaken on (b)(6)2014.The physician relocated the lead and the patient reported effective stimulation coverage postoperatively.

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.

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.

• Brand Name: LAMITRODE TRIPOLE 16C LEAD, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4370068
• MDR Text Key: 5115774
• Report Number: 1627487-2014-15925
• 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,Followup
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 3214
• Device Lot Number: 4610259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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 3789, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 58 YR