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

Model Number	3788
Medical Device Problem Codes	No Apparent Adverse Event (3189); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
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 lost communication with external devices.In turn, the ipg was deemed inoperable.Surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
Per the additional information received, this event no longer meets the reportability criteria.
Event or Problem Description
It was reported that the patient lost therapy on approximately 30may2022, indicating that the ipg reached its expected longevity.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• 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: 15797393
• Report Number: 1627487-2022-06228
• Device Sequence Number: 4791025
• Product Code: LGW
• UDI-Device Identifier: 05415067017307
• UDI-Public: 05415067017307
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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: 01/28/2013
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 3299994
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 12/03/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2011
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS LEAD (X1)
• Patient Sex: Female
• Patient Weight: 73 KG