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 Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 05/21/2018

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#: 1627487-2018-07115.It was reported the patient's stimulation decreases by itself.The patient also states he has fallen multiple times over the past few months.Diagnostic testing revealed invalid impedance readings on multiple lead contacts.In turn, the patient will consult with the physician regarding surgical intervention to address the issue.

Event Description

Device 2 of 2.Reference mfr.Report#: 1627487-2018-07115.Follow-up information revealed the patient is having a fusion and no intervention is planned for the scs system at this time.

Event Description

Additional information received that patient underwent surgical intervention wherein the leads were explanted and replaced.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: jennifer shepard ; 6901 preston road; plano, TX 75024 ; 9725264657
• MDR Report Key: 7737229
• MDR Text Key: 115643482
• Report Number: 1627487-2018-07116
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 3245
• Device Lot Number: 3641758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/24/2018; 10/02/2019; 10/18/2019
• Supplement Dates FDA Received: 09/17/2018; 10/17/2019; 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2012
• 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
• Patient Outcome(s): Other
• Patient Weight: 84