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

Model Number 3788

Device Problems Nonstandard Device (1420); No Device Output (1435); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Field advisories: 1627487-07262012-002-r; 1627487-12192011-003-r.This ipg serial number was included in field advisories.(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.(b)(4).

Event Description

It was reported the patient was unable to establish communication between his ipg and charger.A new charger was forwarded to the patient, which did not resolve the issue.It was also reported the patient's programmer reflected a communication error message.In addition, the patient stated his recharging time gradually increased.It was noted the patient has multiple unrelated health issues and uses a morphine pump.The patient was without stimulation.The sjm representative met with the patient and confirmed the issues.Subsequently, the patient underwent surgical intervention on (b)(6) 2015 where the ipg was removed and replaced with a different model.The patient reported effective stimulation therapy postoperative and the reported issue is now resolved.The event date is unknown.

• 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: 5259175
• MDR Text Key: 32451374
• Report Number: 1627487-2015-23704
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• 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: 175163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1627487-05242011-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other