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

Model Number 3186

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2015-20258.It was reported the patient experienced ineffective and unintended stimulation.A sjm representative tried reprogramming to no avail.X-rays revealed lead migration.Additionally, the patient experienced a fall.Surgical intervention will be taken at a later date to address the issue.Date of event is unknown.

Manufacturer Narrative

Udi (di): (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

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# 1627487-2015-20258.Further follow up identified the patient underwent surgical intervention on 08/21/2015 where one of the scs leads was repositioned and both the leads were re-anchored which resolved the issue.Reportedly, stimulation was restored postoperatively.

• 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: 4737982
• MDR Text Key: 5704911
• Report Number: 1627487-2015-20257
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3186
• Device Lot Number: 4870114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2014
• 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
• Treatment: MODEL 1192(2), SCS ANCHOR
• Patient Outcome(s): Other