MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44C LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3245

Device Problem Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr.Report#1627487-2018-09150.It was reported the patient was involved in a severe motor vehicle accident last year.Reportedly, the patient began experiencing diminished therapy within the last several months.Diagnostic testing identified one lead with invalid impedances.As a result, surgical intervention may be undertaken at a future date to address the issue.

Event Description

Device 2 of 2 : reference mfr.Report#1627487-2018-09150.Follow up information identified the physician explanted the model 3163 lead and replaced it with a new model.Postoperatively, therapy was restored, and the issue was resolved.No intervention was performed on the patient¿s 3245 lead.

• Brand Name: LAMITRODE 44C 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
• Manufacturer Contact: melissa nkematu ; 6901 preston road; plano, TX 75024 ; 9723092520
• MDR Report Key: 7914200
• MDR Text Key: 121874935
• Report Number: 1627487-2018-09151
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 3245
• Device Lot Number: 3795667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2012
• 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(2), SCS ANCHOR; MODEL 3788, SCS IPG
• Patient Outcome(s): Other