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

Model Number 3789

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/16/2014

Event Type  Injury  

Event Description

It was reported the patient was unable to turn her scs system stimulation off.An sjm representative met with the patient and was able to turn the system off and on with both the patient programmer as well as the magnet in magnet mode.The patient was instructed to monitor her system to determine if the issue persisted.Additional information received identified the patient alleged her system continues to turn on and off on its own.Surgical intervention is planned for a later date to address the issue.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history an 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: PROTEGE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 4252860
• MDR Text Key: 5013619
• Report Number: 1627487-2014-08417
• 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: 10/20/2014

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: 07/01/2016
• Device Model Number: 3789
• Device Lot Number: 4686922
• Other Device ID Number: 05414734405690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/11/2014
• 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 3219; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 67 YR