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

Model Number 3788

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/22/2015

Event Type  Injury  

Event Description

It was reported the patient's scs ipg will not charge.The patient stated his scs charger does not communicate with the ipg.The patient stated his scs patient programmer displays a communication error message.A sjm representative met with the patient and confirmed the patient's scs ipg is inoperable.Surgical intervention may be taken at a later date to address the issue.

Manufacturer Narrative

Correction number: 1627487-12192011-003-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.

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.

Event Description

Follow-up identified the patient¿s scs ipg was explanted and replaced with a new one.Effective stimulation therapy was reportedly restored post-operative.

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 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: 4517407
• MDR Text Key: 5494894
• Report Number: 1627487-2015-01049
• 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,Followup,Followup,Followup
• Report Date: 07/16/2015

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: Other
• Device Expiration Date: 11/28/2012
• Device Model Number: 3788
• Device Lot Number: 3244580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/16/2015; 06/17/2015; 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: MODEL 3219, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 61 YR