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

Model Number 3788

Device Problem Device Stops Intermittently (1599)

Patient Problems Fever (1858); Shock (2072); Burning Sensation (2146)

Event Date 12/14/2013

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2013-21024.It was reported the patient rolled over in bed on (b)(6) 2013, after which she experienced a tugging and shocking/tingling/burning sensation at the ipg site.Subsequently, the patient went to the emergency room.The patient stated having a fever prior to being hospitalized.X-rays and diagnostic testing did not reveal any anomalies.The patient also reported experiencing intermittent stimulation.The patient was given new stimulation programs and it was reported she was receiving effective bilateral stimulation.The sjm representative was informed at a later date that the patient has a red line from the ipg site to the lead site (lead reported as device 2) and the physician recommended turning off the scs system to see if the patient's symptoms subside.Additionally, the patient underwent gastric surgery on (b)(6) 2013 and will be consulting with the physician regarding the scs system 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 MINI
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3673907
• MDR Text Key: 4304452
• Report Number: 1627487-2014-21014
• 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: 12/15/2013

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: 3788
• Device Lot Number: 4068309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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): Hospitalization
• Patient Age: 36 YR