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 2 of 2.Reference mfr report 1627487-2014-02886.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.

• 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: 4381511
• MDR Text Key: 5362242
• Report Number: 1627487-2014-02887
• 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
• Type of Report: Initial
• Report Date: 12/08/2014

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: 02/01/2014
• Device Model Number: 3186
• Device Lot Number: 3617677
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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: SCS IPG: MODEL 3788; IMPLANT DATE:; IMPLANT DATE:; SCS ANCHOR: MODEL 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 48 YR