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

Model Number 3186

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/02/2014

Event Type  Injury  

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 # 1627487-2014-08173.It was reported the patient was experiencing scs stimulation turning on and off by itself.A sjm representative met with the patient for reprogramming and was able to provide effective stimulation.Additional information received identified the patient's lead impedances are now entirely invalid.A x-ray did not reveal any anomalies.Surgical intervention is planned for a later date to address the issue.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 4008965
• MDR Text Key: 19396497
• Report Number: 1627487-2014-08172
• 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: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• 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: 07/15/2014
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS IPG: MODEL 3788; IMPLANT DATE:; IMPLANT DATE:; SCS ANCHOR: MODEL 1192 (X2)
• Patient Outcome(s): Other
• Patient Age: 41 YR