MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 88 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3288

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

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 10/27/2014

Event Type  Injury  

Event Description

It was reported the patient was hospitalized on (b)(6) 2014 due to a mrsa infection at the lead site.As a result, surgical intervention was undertaken explanting the entire scs system.The patient was treated inpatient with iv antibiotics oral therapy.

Manufacturer Narrative

(b)(4).Evaluation codes: 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 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: LAMITRODE 88 LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4310523
• MDR Text Key: 5208043
• Report Number: 1627487-2014-01782
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 3288
• Device Lot Number: 4525770
• Other Device ID Number: 05414734402248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• 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: MODEL 3383(2), SCS EXTENSION, IMPLANT DATE:; MODEL 3788, SCS IPG, IMPLANT DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR