MAUDE Adverse Event Report: ST. JUDE MEDICAL NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problems Failure to Charge (1085); Nonstandard Device (1420); No Device Output (1435); Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/03/2015

Event Type  Injury  

Event Description

It was reported the ipg has been inoperable since 2011 due to the patient's failure to recharge the scs system.As a result, surgical intervention was undertaken on (b)(6) 2015.The original ipg was explanted and replaced with a new non-rechargeable model in the abdominal region.The procedure went without incident.The issue is resolved.

Manufacturer Narrative

Udi(di) (b)(4).This ipg serial number was included in field advisories.1627487-05242011-002-r, 1627487-12192011-003-r.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 IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL NEUROMODULATION; 6901 preston road; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL NEUROMODULATION; 6901 preston road; plano TX 75024
• MDR Report Key: 4867690
• MDR Text Key: 5860646
• Report Number: 1627487-2015-08376
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: 3788
• Device Lot Number: 175591
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: MODEL 1194(2), SCS ANCHOR; MODEL 3288, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 49 YR