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

Model Number	3688
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported the patient's ipg has reached its end of service.Surgical intervention may take place at a later date.
Additional Manufacturer Narrative
E1 reporter phone number: (b)(6).
Additional Manufacturer Narrative
A depleted ipg was reported to abbott.The implant was replaced to reestablish effective therapy.The old ipg was not returned for evaluation.Stimulation settings are not available.In absence of complete stimulation parameters and settings, it is not possible to perform an accurate longevity calculation.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.Based on the information received, the ipg¿s longevity estimation could not be accurately determined and a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: EON C 16-CHANNEL IPG
• Common Device Name: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11475098
• Report Number: 1627487-2021-02044
• Device Sequence Number: 14403224
• Product Code: LGW
• UDI-Device Identifier: 05415067017369
• UDI-Public: 05415067017369
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2018
• Device Model Number: 3688
• Device Catalogue Number: 3688
• Device Lot Number: 5494389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 05/17/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/30/2021; 05/18/2021
• 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