MAUDE Adverse Event Report: ABBOTT MEDICAL SCS ANCHOR

Model Number	NMD0014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient was experiencing swelling from their drg implant.Surgical intervention occurred where the anchors were explanted to address the issue.
Additional Manufacturer Narrative
It was reported to abbott, a patient underwent a revision to remove anchors from the system due to swelling around them.The physician believed the patient reacted to silk sutures used to hold the anchors in place.There were no complications.The device was not returned for evaluation.Based on the information received, the cause of the reported issue was determined not to be product related.

• Brand Name: SCS ANCHOR
• Common Device Name: ANCHOR
• 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: 16842995
• Report Number: 1627487-2023-01985
• Device Sequence Number: 15170978
• Product Code: LGW
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/04/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: NMD0014
• Device Catalogue Number: 1192
• 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: 04/07/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: DRG IPG; DRG LEAD X2
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 77 KG