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

Model Number 3186

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient (b)(6) underwent an implant procedure.During the procedure, the doctor was unable to remove the stylet from the lead intended for use.In turn, the stylet broke inside of the lead as a result of the doctor applying force.Another lead was used to successfully complete the procedure.The procedure was extended by an hour.Patient information is unknown.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

Evaluation codes: results the complaint of ¿can¿t remove stylet¿ was confirmed.As received, the stylet returned had five abnormal bends 3cm, 16cm, 28cm, 35cm, and another 55cm away from the tip; and with a broken handle.Optical inspection of the returned lead body was clear.Both stimulation and terminal ends were in good condition, and no broken wires or kinks in the lead body were observed.The inner stylet lumen (stylet tubing) was buckled/collapsed approximately 16cm from the terminal end of the lead.A lab stylet was inserted and extracted with slight resistance.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 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
• MDR Report Key: 4487578
• MDR Text Key: 5344661
• Report Number: 1627487-2015-05052
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 3186
• Device Lot Number: 4833438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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