MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON; SCS IPG

Model Number 3716

Device Problems No Device Output (1435); Use of Device Problem (1670); Moisture or Humidity Problem (2986)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/27/2014

Event Type  Injury  

Event Description

It was reported the patient's ipg was depleted due to inability to recharge the ipg.The patient lost 140 pounds and the ipg could not communicate with the ipg.The ipg was explanted and replaced.The physician connected the existing leads to the ipg and the patient reported receiving effective stimulation therapy.

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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie thomas ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 3979850
• MDR Text Key: 15819094
• Report Number: 1627487-2014-12498
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2010
• Device Model Number: 3716
• Device Lot Number: 171617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2008
• 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: SCS LEADS: MODEL 3186 (X2); IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 39 YR