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

Model Number 3219

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 02/26/2015

Event Type  Injury  

Event Description

It was reported the during the patient's perm implant procedure effective therapy was not established.The patient underwent surgical intervention on (b)(6) 2015 to reposition the lead.However, the physician had difficulty placing the lead at the intended position due to patient's anatomy and scar tissue.Physician was able to get the lead to where needed and procedure was completed.Patient was doing "well" postoperatively.Further follow up identified later the patient experienced abdominal spasm and subsequently, the physician explanted the scs system.

Manufacturer Narrative

(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: LAMITRODE TRIPOLE 16 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 road; plano TX 75024
• MDR Report Key: 4613959
• MDR Text Key: 5763224
• Report Number: 1627487-2015-20173
• 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: 02/26/2015

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 Expiration Date: 01/28/2017
• Device Model Number: 3219
• Device Lot Number: 4945336
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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 3789, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 50 YR