MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION PROTEGE; SCS IPG

Model Number 3789

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

Patient Problems Discharge (2225); Post Operative Wound Infection (2446)

Event Date 09/08/2014

Event Type  Injury  

Event Description

It was reported during post-implant visit, the ipg site showed signs of an infection with discharge present.As a result, surgical intervention was undertaken, explanting the scs system.The sjm rep was not present for the procedure.It is undetermined if cultures were taken.

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 info 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: PROTEGE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 4176553
• MDR Text Key: 5093951
• Report Number: 1627487-2014-01640
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: 3789
• Device Lot Number: 4689667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: SCS LEAD, MODEL: 3228; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 51 YR