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

Model Number 3186

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

Patient Problems Cellulitis (1768); Post Operative Wound Infection (2446)

Event Date 04/15/2014

Event Type  Injury  

Event Description

Device 2 of 3.Reference mfr report: 1627487-2014-06138, 06140.It was reported, the pt was hospitalized on (b)(6) 2014 due to an infection at his ipg site and lead site.He underwent surgical intervention on (b)(6) 2014, where his incisions were opened to drain and clean.The pt was treated with iv antibiotics and was referred to an infectious disease doctor.Follow up information confirmed culture results for cellulitis.The pt continues to be treated with iv antibiotics.

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 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 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: kimberly goode ; 6901 preston rd.; plano, TX 75024 ; 9723098541
• MDR Report Key: 3848837
• MDR Text Key: 20017201
• Report Number: 1627487-2014-06139
• 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: 04/28/2014

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: 10/01/2015
• Device Model Number: 3186
• Device Lot Number: 4284709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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 ANCHOR: MODEL 1192 (2); IMPLANT DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR