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

Model Number 3788

Device Problems Premature Discharge of Battery (1057); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/28/2014

Event Type  Injury  

Event Description

It was reported the pt experienced increased recharge burden.The ipg was unable to hold a charger for a day.Per the sjm representative blood was observed in both the lead parts of the ipg.As a result, the ipg was explanted and replaced which has resolved the issue.

Manufacturer Narrative

This ipg serial number included in field advisories.Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt'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: taruna sharma ; 6901 preston rd.; plano, TX 75024 ; 9725269635
• MDR Report Key: 4098655
• MDR Text Key: 4704004
• Report Number: 1627487-2014-20210
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2013
• Device Model Number: 3788
• Device Lot Number: 3389163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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 LEAD: MODEL 3186(2); IMPLANT DATE:; SCS LEAD: MODEL 3228; IMPLANT DATE:; IMPLANT DATE:; SCS ANCHOR: MODEL 1194(2); SCS ANCHOR: MODEL 1194(2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 78 YR