MAUDE Adverse Event Report: ST. JUDE MEDICAL -NEUROMODULATION LAMITRODE TRIPOLE 16; SCS LEAD

Model Number 3219

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

Patient Problems Bacterial Infection (1735); Fever (1858); Post Operative Wound Infection (2446)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report #1627487-2014-12430.Reference mfr report #1627487-2014-12431.It was reported the patient had an infection at the incision where the lead attaches to the lead extension.The scs system was explanted.The patient had a fever and was hospitalized for a week and was given intravenous antibiotics.The patient was released to home with two weeks of intravenous antibiotics with a picc line.The cultures confirmed a (b)(6) infection.Follow up revealed the infection has cleared.

Manufacturer Narrative

Method: the device history 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 TRIPOLE 16
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL -NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 3949242
• MDR Text Key: 4535340
• Report Number: 1627487-2014-12429
• 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: 05/30/2014

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: Other
• Device Expiration Date: 09/01/2014
• Device Model Number: 3219
• Device Lot Number: 3813652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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 DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR