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

Model Number 3788

Device Problems Nonstandard Device (1420); Communication or Transmission Problem (2896); Unintended Movement (3026)

Patient Problems Inadequate Pain Relief (2388); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

Results: the complaint was confirmed.As returned, the ipg would not communicate due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg passed all tests.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.

Event Description

It was reported the patient lost stimulation approximately a month ago.In addition, the ipg will no longer communicate with the charger.Follow-up information identified the ipg had flipped in the pocket due to the patient 's weight loss.Surgical intervention was undertaken on (b)(6) 2015 and the ipg was explanted and replaced with a different model.Stimulation was restored postoperatively thus resolving the issue.

Manufacturer Narrative

Udi(di) (b)(4).This ipg correction number was included in field advisories.1627487-05242011-002-r, 1627487-07262012-002-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 rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4795631
• MDR Text Key: 14378653
• Report Number: 1627487-2015-08299
• 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,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2011
• Device Model Number: 3788
• Device Lot Number: 2865284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2009
• 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 3214, SCS LEAD
• Patient Outcome(s): Other