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

Model Number 3189

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Post Operative Wound Infection (2446)

Event Date 06/01/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr.Report#: 1627487-2014-05780.It was reported the pt had a bump and a sore scab with drainage at the lead site.Pus and drainage remained present during the following months.Follow-up revealed the pt's scs system was explanted due to infection.Cultures were taken and came back negative.It is unk if the pt was given antibiotics to address the infection.

Manufacturer Narrative

Method: the device history and sterilization record were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies were found.Conclusion: the cause of the reported complaint could not be determined form the review of the dhr and sterilization records.Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: OCTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4265013
• MDR Text Key: 5006864
• Report Number: 1627487-2014-05781
• 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: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: 3189
• Device Lot Number: 4210954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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:
• Patient Outcome(s): Other
• Patient Age: 39 YR