MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION OCTRODE; SCS LEAD

Model Number 3186

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/30/2014

Event Type  Injury  

Event Description

Device 1 of 2.Ref mfr report: 1627487-2014-03496.It was reported the pt is experiencing auto-reduction and tenderness at the scs ipg pocket site regardless of stimulation.Diagnostics identified invalid impedance values for the scs leads.It was slo reported x-rays revealed both leads are kinked at the anchor sites.The pt is deciding whether to undergo surgical intervention or not to address the issues.

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.

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: 1627487-2014-03496.Further investigation identified surgical intervention will be taken to address the issues.

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:1627487-2014-03496.Additional information received identified the patient's scs leads were explanted and replaced with a different model which resolved the issue.It was also reported the scs ipg became inoperable and was also explanted and replaced.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION ; plano TX
• Manufacturer Contact: racheal blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264367
• MDR Report Key: 3960870
• MDR Text Key: 4558786
• Report Number: 1627487-2014-03490
• 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: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: 3186
• Device Lot Number: 3939865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS ANCHORS: MODEL 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 51 YR