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 05/05/2014

Event Type  Injury  

Event Description

Device i of 2.Reference mfr report #: 1627487-2014-08045.It was reported the pt was experiencing intermittent stimulation beginning on (b)(6) 2014.An sjm rep met with the pt and confirmed invalid scs system impedances.The rep was able to reprogram the pt to provide stimulation in the desired areas but the stimulation was abrupt when turning-up the amplitude.Pt met with his physician on (b)(6) 2014 and had a ct scan.Pt is going to f/u with his physician to evaluate results of ct and determine the next course of action to address the issue.

Manufacturer Narrative

Sjm has limited info 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: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 3919138
• MDR Text Key: 19298259
• Report Number: 1627487-2014-08044
• 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: 05/23/2014

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: 03/01/2010
• Device Model Number: 3186
• Device Lot Number: 115539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• 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: IMPLANT DATE:; SCS IPG: MODEL 3716
• Patient Outcome(s): Other
• Patient Age: 78 YR