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

Model Number 3788

Device Problem Delayed Charge Time (2586)

Patient Problem No Code Available (3191)

Event Date 11/28/2014

Event Type  Injury  

Event Description

It was reported the patient's ipg is experiencing an increased recharge burden and the charge duration is less than 24 hours.X-rays were taken as the next course of action.Follow-up identified surgical intervention was undertaken, explanting and replacing the ipg.Effective therapy was achieved postoperatively.

Manufacturer Narrative

(b)(4).Udi (di) (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.

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 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
• Manufacturer Contact: st. jude medical - neuromodulation; 6901 preston road; plano, texas 75024
• MDR Report Key: 4442157
• MDR Text Key: 5385475
• Report Number: 1627487-2015-08027
• 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,Followup
• Report Date: 03/18/2015

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: 01/28/2014
• Device Model Number: 3788
• Device Lot Number: 3599352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 01/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2012
• 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 3189(2), SCS LEAD, IMPLANT DATE:; MODEL 1192(2), SCS ANCHOR, IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 32 YR