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

Model Number 3086

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

Patient Problems Abscess (1690); Pain (1994)

Event Date 06/17/2014

Event Type  Injury  

Event Description

Device 1 of 2.Ref mfr report: 1627487-2014-15561.The pt underwent a procedure for a trial scs system on (b)(6) 2014 and approx 6 days later, the pt experienced pain and went to the emergency room.It was determined the pt had an abscess.The location of the abscess was not provided and it is unk if cultures were taken.The pt was placed on iv antibiotics and the abscess has since resolved.

Manufacturer Narrative

Method - the device history and sterilization records were reviewed.Results - the device history and sterilization records reviewed were found to meet specs and no anomalies related to this event 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 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: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 3960225
• MDR Text Key: 4605352
• Report Number: 1627487-2014-15560
• 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: 07/01/2014

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: 04/01/2016
• Device Model Number: 3086
• Device Lot Number: 4583900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR