MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S8; SCS LEAD

Model Number 3286

Device Problems Cut In Material (2454); Failure to Advance (2524)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/30/2013

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-15059.It was reported, the pt underwent surgical intervention to explant and replace his scs system (reference mfr reports: 1627487-2013-21441, 1627487-2013-21442, 1627487-2013-21443, 1627487-2013-21444 and 1627487-2013-21464) on (b)(6) 2013.During the procedure, a lead was placed but the pt experienced abdominal stimulation.The physician was unable to reposition the lead due to resistance and upon removing the lead, it was sheared (device 1).A second lead (device 2) was attempted to be placed, but again the physician encountered resistance while attempting to position the lead.The physician was able to complete the procedure using 2 different model leads and effective stimulation was established.It is estimated the procedure was extended by approximately 1.5 hours.

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 S8
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 3596350
• MDR Text Key: 4091667
• Report Number: 1627487-2014-15058
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: 3286
• Device Lot Number: 4000169
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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 Age: 46 YR