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

Model Number 3788

Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/12/2014

Event Type  Injury  

Event Description

It was reported the patient's ipg was replaced and the pocket site was relocated.Lead diagnostics showed all contacts except for #2 and #6 were normal.Fluid was noted in the ipg header and the 9-16 set screw was loose.The patient was experiencing charging issues due to the ipg flipping and had not used the system in 2 months.The patient's 2 scs extensions were explanted (not replaced) due to repositioning of the pocket site.The patient is now receiving effective stimulation.

Manufacturer Narrative

(b)(4).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 rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4381758
• MDR Text Key: 5124067
• Report Number: 1627487-2015-10004
• 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
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 3788
• Device Lot Number: 3922274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2013
• 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: MODEL 3228, SCS LEAD, IMPLANT DATE:; MODEL 3383 (2), SCS EXTENSION, IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 45 YR