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

Model Number 3788

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/21/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report # 1627487-2014-12348.It was reported the pt post stimulation.An sjm rep interrogated the pt's system one week post implant procedure.All of the contacts had invalid impedance on one of the leads.An x-ray revealed the lead pulled out of the ipg header.The pt's lead revision procedure was (b)(6) 2014.The physician reattached to leads to the ipg but there were impedance issues.The physician noticed fluid in the ipg header.The ipg was explanted and replaced.Extensions were attached to the existing leads then connected to the new ipg.The pt's stimulation was restored.Note the pt received two leads, occipital placement (off label use), from the same lot number.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 3820880
• MDR Text Key: 4451654
• Report Number: 1627487-2014-12347
• 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: 04/21/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 3788
• Device Lot Number: 4405770
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 38 YR