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

Model Number 3186

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  Injury  

Manufacturer Narrative

Result: the complaint of ¿can¿t remove stylet¿ was confirmed.As received, visual inspection of the returned stylet had nine abnormal bends 2 cm, 5 cm, 13 cm, 29 cm, 36 cm, 45 cm, 50 cm, 62 cm, and another 64 cm away from the tip; and with a broken handle.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

It was reported during the scs lead revision surgery the physician (b)(6) was unable to remove stylet from the lead.As a result the lead was explanted and replaced.The procedure was extended for about 90 minutes.

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 LEAD KIT, 60 CM LENGTH
• Manufacturer (Section D): ST JUDE MEDICAL NEUROMODULATION; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION
• Manufacturer Contact: taruna sharma ; 6901 preston rd.; plano, TX 75024
• MDR Report Key: 4532728
• MDR Text Key: 12844538
• Report Number: 1627487-2015-20016
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/30/2015

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 Model Number: 3186
• Device Lot Number: 173008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2008
• 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