MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3286

Device Problems Break (1069); High impedance (1291)

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

Event Date 02/09/2018

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

It was reported the patient experienced ineffective stimulation.The patient fell approximately a month ago.Reprogramming was attempted; however patient felt stimulation only in certain positions.Diagnostics indicated high impedances.X-rays indicated a possible break in the lead.Subsequently, surgical intervention was undertaken on (b)(6) 2018 during which the cervical lead was explanted and replaced.Stimulation was restored following the procedure.

• Brand Name: LAMITRODE S-8 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: palka sharma ; 9725264823
• MDR Report Key: 7839153
• MDR Text Key: 118959419
• Report Number: 1627487-2018-08021
• 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
• Report Date: 08/31/2018

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: 07/28/2012
• Device Model Number: 3286
• Device Lot Number: 3162647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2010
• 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, SCS ANCHOR; MODEL 3662, SCS IPG
• Patient Outcome(s): Other