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

Model Number 3788

Device Problems No Device Output (1435); Charging Problem (2892); Contamination /Decontamination Problem (2895)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/27/2014

Event Type  Injury  

Event Description

Device 1 of 5.Reference mfr.Report#: 1627487-2014-23652, reference mfr.Report#: 1627487-2014-23654, reference mfr.Report#: 1627487-2014-23658, reference mfr.Report#: 1627487-2014-23659.It was reported the patient is experiencing an uncomfortable surge from the ipg to his legs.The sjm representative met with the patient and determined the patient's ipg is inoperable.In addition, no communication could be established between the patient's ipg and external devices.The patient's programmer also reflects a communication error.The patient attempted to recharge the ipg; however, he was unsuccessful.The patient is without stimulation.Surgical intervention will be undertaken as the next course of action.

Manufacturer Narrative

(b)(4).This ipg serial number was included in field advisories.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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 4151926
• MDR Text Key: 18925076
• Report Number: 1627487-2014-23649
• 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: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2011
• Device Model Number: 3788
• Device Lot Number: 2867468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR, MODEL: 1192 (2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 49 YR