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

Model Number 3228

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

Patient Problem Bacterial Infection (1735)

Event Date 09/06/2014

Event Type  Injury  

Event Description

It was reported the pt went to the emergency room complaining of pain and swelling at the lead site and was given pain medications sent home.Two days later the pt was seen by the implanting physician who noted signs of infection.The pt was admitted to the hosp and iv antibiotics were started.The physician found the lead site was infected and the infection had spread to the ipg.Both devices were explanted.Cultures were taken and confirmed a (b)(6) infection.The pt was sent home and will continue iv antibiotics for six weeks.

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: batch records review for 4606184 showed non-conformances related to insufficient material from the warehouse, labeling defects and foreign material.Some units were replaced and the device shown to be manufactured per specs.Some units were reprinted and the remaining units were scrapped.As nonconforming units were not distributed, these non-conformance could not have contributed to the product failure identified in the complaint for 'infection'.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: PENTA
• 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: 4151802
• MDR Text Key: 4927239
• Report Number: 1627487-2014-12657
• 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: 09/08/2014

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: 05/01/2016
• Device Model Number: 3228
• Device Lot Number: 4606184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: IMPLANT DATE:; SCS IPG, MODEL 3788,
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR