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

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Weakness (2145)

Event Date 08/31/2016

Event Type  Injury  

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.(b)(4).

Event Description

Device 1 of 2.Reference mfr report#1627487-2016-04940.It was reported the patient presented to the er due to leg weakness and a loss of bowel and bladder control.Reportedly, x-rays revealed both leads were anterior in the epidural space.As a result, surgical intervention was scheduled as the next course of action to address the issue.Follow-up identified the procedure took place on (b)(6) 2016 at which time both leads were explanted and replaced with one new lead.Bilateral coverage was achieved postoperatively.The issue is resolved.

• 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: 5970236
• MDR Text Key: 55366297
• Report Number: 1627487-2016-04937
• 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
• Report Date: 09/01/2016

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: 11/30/2017
• Device Model Number: 3186
• Device Lot Number: 5315777
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• 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; MODEL 3771, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 58 YR