MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODUALATION QUATTRODE; SCS LEAD

Model Number 3169

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

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

Event Date 09/23/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr.Report #: 1627487-2014-05703.The patient has two 3166 leads from the same lot.It was reported the patient was experiencing purulent discharge at one of the lead sites.In turn, the patient was diagnosed with an infection and was given antibiotics.Follow-up revealed cultures were taken and came back negative for staphylococcal infection.The infection remains ongoing and the next course of action is unknown at this time.

Manufacturer Narrative

Method - the device history and sterilization records 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 from the review of the dhr and sterilization records.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: QUATTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODUALATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4180113
• MDR Text Key: 18258728
• Report Number: 1627487-2014-05704
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• 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: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: 3169
• Device Lot Number: 4524767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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 EXTENSIONS: MODEL 3346; IMPLANT DATE:; SCS IPG: MODEL 3789; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 28 YR