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

Model Number 3186

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Inadequate Pain Relief (2388); Shock from Patient Lead(s) (3162)

Event Date 04/18/2014

Event Type  Injury  

Event Description

The pt was implanted two scs leads from the same lot number.It was reported the pt complained of an "electrical surge" at her scs ipg site during her charging session when the ipg is almost fully charged.A sjm rep met with the pt and confirmed the pt experiences frequent jolting at her scs ipg site that radiated up her back to approximately her bra level.The rep was unable to resolve the issue with reprogramming.In addition, the rep observed the pt was no receiving stimulation in her foot.Follow up on (b)(4) 2014 identified the pt's scs leads were explanted and replaced.The pt reported post-op her stimulation was comfortable with no jolting.

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: 3821255
• MDR Text Key: 22136696
• Report Number: 1627487-2014-02320
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/18/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: 3186
• Device Lot Number: 4131100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS IPG: MODEL 3788; IMPLANT DATE:; SCS ANCHOR: MODEL 1192
• Patient Outcome(s): Other
• Patient Age: 45 YR