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

Model Number 3788

Device Problem Unintended Movement (3026)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 08/27/2014

Event Type  Injury  

Event Description

Follow up information identified the patient underwent surgical intervention to replace the patient's ipg.

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.

Event Description

It was reported the patient experienced significant overstimulation while her ipg was turned off.She was unable to stand or walk.When her ipg first communicated with the programmer, the programmer did not display any amplitude bars signifying any ipg output.The patient was able to power down the ipg.The patient is receiving stimulation.Follow up information identified a sjm representative met with the patient and lead diagnostics were within normal limits.Xrays were taken and revealed the ipg is perpendicular to the skin.Surgical intervention is pending.

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.

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 MINI
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS; plano TX
• Manufacturer (Section G): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston road; plano TX 75024
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4369795
• MDR Text Key: 6190706
• Report Number: 1627487-2014-22043
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 09/04/2015

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: 06/01/2015
• Device Model Number: 3788
• Device Lot Number: 4213536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 61 YR