MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON

Model Number 3716

Device Problem Battery Problem: High Impedance (2947)

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

Event Date 12/20/2013

Event Type  Injury  

Event Description

Device 1 of 3.Ref.Mfr reports: 1627487-2014-02051, 02052.It was reported during the pt's scs permanent implant procedure high impedances were observed when testing the system intraoperatively.The leads were disconnected and tested separately, impedances were still high but not as high.The leads were then reversed but the impedances did not change.The ipg was replaced but the issue persisted.The physician completed the procedure.A full system diagnostics was performed postoperative and all was within normal ranges.The pt's system was programmed and effective stimulation therapy was obtained.The procedure was extended by approximately 40 minutes.

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
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3682555
• MDR Text Key: 4260957
• Report Number: 1627487-2014-02050
• 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: 12/20/2013

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Model Number: 3716
• Device Lot Number: 4050206
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/31/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR