MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3086

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problems Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 12/02/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2014-20514.

Manufacturer Narrative

Result: the complaint of ¿can¿t remove stylet¿ was confirmed.As received, visual inspection of the returned stylet had five abnormal bends.The damage observed on the stylet was consistent with the overstress conditions the stylet was subjected to during the implant procedure.These abnormal bends would account for the stylet not being able to be retracted from the lead.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.

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2014-20514.It was reported during patient's trial procedure the physician was unable to remove stylet from the lead.During trouble shooting the lead was moved.In turn, the physician explanted the lead and tried another one which the physician was not able to place it in the epidural space.The patient experienced unintended stimulation.The physician tried troubleshooting to no avail.Subsequently, the lead was explanted and the trial procedure was abandoned.

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: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4358017
• MDR Text Key: 5756340
• Report Number: 1627487-2014-20513
• 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,Followup
• Report Date: 03/06/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3086
• Device Lot Number: 4771704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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: 45 YR