MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON PATIENT PROGRAMMER; SCS PATIENT PROGRAMMER

Model Number 3851

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

It was reported the patient's (+) button on her programmer is working intermittently and appears to be sticking.A replacement programmer was sent to the patient to address the issue.

Manufacturer Narrative

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: EON PATIENT PROGRAMMER
• Type of Device: SCS PATIENT PROGRAMMER
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 3785971
• MDR Text Key: 4377382
• Report Number: 1627487-2014-23094
• 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: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 3851
• Device Lot Number: 3829183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: IMPLANT:; IMPLANT:; SCS IPG: MODEL 3788; SCS LEAD: MODEL 3286 (2); SCS ANCHOR: MODEL 1192 (2); IMPLANT:
• Patient Age: 72 YR