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

Model Number	3688
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the ipg reached end of life.It is unknown if the ipg depleted prematurely.Surgery to replace the ipg may occur in the future to address this issue.
Additional Manufacturer Narrative
Correction: manufacturing reference number 1627487-2022-04891 should not have been reported as a medical device report (mdr) after additional information received confirmed the end of life calculations exhibit what the patient is experiencing, confirming normal device characteristics and thus no longer reportable.
Event or Problem Description
Additional information received indicated the the ipg exhibited normal device characteristics and confirmed the device depleted normally.

• Brand Name: EON C 16-CHANNEL IPG
• Common Device Name: 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: 15369368
• Report Number: 1627487-2022-04891
• Device Sequence Number: 13884716
• Product Code: LGW
• UDI-Device Identifier: 05414734402460
• UDI-Public: 05414734402460
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 3697140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown