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

Model Number 3716

Device Problem Pocket Stimulation (1463)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 01/30/2024

Event Type  Injury  

Event Description

Related manufacturer report number:1627487-2024-07093.It was reported that the patient was experiencing pocket site heating and a shocking sensation near the site of the ipg.The patient noted they were feeling these sensations when therapy was active.Surgical intervention may take place at a later date to address the issue.

Manufacturer Narrative

Section a4: during processing of this incident, attempts were made to obtain patient weight.Further information was requested but not received.Section b3: event date is estimated.

Manufacturer Narrative

It was reported to abbott, a patient had been experiencing warmth and shocking at the pocket site when the therapy was on and had not used it within the past year.The rep met with the patient who stated the sensations occurred when stimulation was turned on.A lead diagnostic resulted in an error message.It¿s unknown if there were any impedance issues.The patient wanted the ipg replaced.Surgery was scheduled but cancelled.As of (b)(6) 2024, surgery had not been rescheduled.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.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18744554
• MDR Text Key: 335809766
• Report Number: 1627487-2024-07094
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 3716
• Device Lot Number: 3641087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2012
• 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 LEAD (X1); SCS LEAD ANCHOR(X2)
• Patient Outcome(s): Other
• Patient Sex: Female