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

Model Number 3186

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/30/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-02887.It was reported the patient has been unable to increase her scs stimulation.The patient's husband stated all of the patient's scs system programs auto-reduce when the amplitude is increased.Fluoroscopy imaging showed there appears to be a kink around either side of the lead(s) anchors.Surgical intervention may be taken at a later date to address the issue.

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 #2.Reference mfr report: 1627487-2014-02887.Follow-up identified the patient's scs leads were explanted and replaced.The patient is reportedly satisfied with the results of the surgery.

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: 1627487-2014-02887.

Manufacturer Narrative

Evaluation codes: microscopic inspection of the lead bodies revealed a lead breakage with all wires broken.The reported event was confirmed.The broken wires would have caused high impedance; which will cause the ipg to auto-reduce.In addition, the broken wires are consistent with the overstress condition the leads are subjected while implanted in the patient.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: 1627487-2014-02887.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 4381508
• MDR Text Key: 17217952
• Report Number: 1627487-2014-02886
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: 3186
• Device Lot Number: 3708673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2015
• Date Manufacturer Received: 03/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG: MODEL 3788; IMPLANT DATE:; IMPLANT DATE:; SCS ANCHOR: MODEL 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 48 YR