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

Model Number 3788

Device Problems Device Inoperable (1663); Use of Device Problem (1670); Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Date 06/01/2013

Event Type  Injury  

Event Description

It was reported the patient has not charged her scs ipg in approximately a year.A sjm representative met with the patient and confirmed the patient's ipg battery is depleted and the ipg is inoperable.Surgical intervention may be undertaken at later date to address the issue.

Event Description

Additional information identifed the patient's scs ipg was explanted and replaced with a new one.In addition, the patient reported losing a significant amount of weight, and the ipg was causing discomfort.During the procedure, the ipg was found to have flipped inside the pocket.Additional follow-up identified effective stimulation therapy was restored postoperative, and the discomfort issue is resolved.

Manufacturer Narrative

Correction umber: 1627487-07262012-002-r.This ipg serial number was included in field advisories.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
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX 75024
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3950296
• MDR Text Key: 4638385
• Report Number: 1627487-2014-02439
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2010
• Device Model Number: 3788
• Device Lot Number: 173835
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 06/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-12192011-003-R
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS LEAD: MODEL 3214
• Patient Outcome(s): Other
• Patient Age: 50 YR