MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/23/2015

Event Type  Injury  

Event Description

It was reported surgical intervention may be undertaken to revise the supra-orbital lead and ipg.The reason for the procedure is currently unknown at this time.

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.

Event Description

Follow-up identified lead migration.Surgical intervention was undertaken on (b)(6) 2015 whereas the lead was secured in place with an anchor.Therapy was restored postoperatively.The issue is resolved.

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, 90CM 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 road; plano TX 75024
• MDR Report Key: 4528889
• MDR Text Key: 5545214
• Report Number: 1627487-2015-08064
• 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: 02/17/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 3189
• Device Lot Number: 4078707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 02/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2013
• 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
• Treatment: MODEL 3343, SCS EXTENSION; MODEL 3169(2), SCS LEAD; MODEL 3688, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 39 YR