MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; 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 10/27/2014

Event Type  Injury  

Event Description

The patient (b)(6) received two leads.This event is related to the right-side lead.It was reported the patient experienced auto-reduction through the scs system.Diagnostics revealed multiple invalid impedance values on the affected lead.Reprogramming was unsuccessful.Subsequently, the patient underwent surgical intervention to explant and replace the affected lead.A visible kink was observed on the explanted lead.The physician electively replaced the ipg as well due to its age.Effective therapy was restored post-operatively.The implant date of the anchor (model 1192) is unknown.The model and implant date of the left-side lead is unknown.

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.

Manufacturer Narrative

Results: the complaint for ¿auto-reducing/ invalid impedance¿ was confirmed.As received, microscopic inspection revealed that the lead had a kink 16.5 cm from the stimulation end where all of the internal wires were broken, and a cam impression from the swift-lock anchor.As there was no breach of the outer tubing and invalid impedance was observed prior to the revision, the fracture is consistent with an overstress condition the lead was subjected to distal end of the swift-lock while it was still implanted.The returned swift-lock anchor had no anomalies and functioned as designed.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, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, tx
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4332450
• MDR Text Key: 5222737
• Report Number: 1627487-2014-21776
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 01/15/2015

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 Expiration Date: 01/28/2013
• Device Model Number: 3186
• Device Lot Number: 3286429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/29/2015; 02/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2011
• 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 3716, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 60 YR