MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problems No Apparent Adverse Event (3189); Wireless Communication Problem (3283)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2023

Event Type  Injury  

Event Description

It was reported the patient¿s ipg was unable to communicate with external devices.A manufacturer representative confirmed the issue and the ipg deemed inoperable.Surgical intervention may be taken at a later date to address the issue.

Manufacturer Narrative

Date of event is esimated.

Manufacturer Narrative

An event of inoperable ipg was reported to abbott.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.During processing of this incident, attempts were made to obtain complete event, patient and device information.Further information was requested but not received.

Manufacturer Narrative

A patient's ipg was inoperable was reported to abbott.It was also determined high impedance was observed.As a result, the patient's ipg explanted and replaced.Effective therapy was restored.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

Event Description

It was reported that the patient had their ipg replaced on (b)(6) 2023.The reason for the replacement is because the ipg had died after 132 months of implant.Since the ipg has exceeded the 10 year minimum rechargeable battery longevity, device is no longer reportable for meeting normal battery depletion.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16233762
• MDR Text Key: 308008845
• Report Number: 1627487-2023-00319
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: 05414734402651
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

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: 01/28/2013
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 3286302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 02/08/2023; 03/05/2023
• Supplement Dates FDA Received: 02/10/2023; 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2011
• 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 PERM LEAD ANCHOR X2; SCS PERM LEAD X1
• Patient Outcome(s): Other
• Patient Sex: Female