MAUDE Adverse Event Report: ABBOTT MEDICAL 8-CHANNEL ADAPTER, BSX, 10CM; SCS ADAPTER

Model Number	2321
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Patient's weight was requested but was not received.Additional components potentially involved in the event include: common device name: scs adapter, model: 2321, udi: (b)(4), serial: (b)(6), batch: 8176972.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
Event or Problem Description
It was reported patient experienced shocking at the lead site.Surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
Correction: additional information received indicates the adapter did not contribute to the event.This device is no longer considered reportable.

• Brand Name: 8-CHANNEL ADAPTER, BSX, 10CM
• Common Device Name: SCS ADAPTER
• 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: 21023892
• Report Number: 1627487-2024-12881
• Device Sequence Number: 15709007
• Product Code: LGW
• UDI-Device Identifier: 05415067016713
• UDI-Public: (01)05415067016713(10)7700337(17)221014
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/28/2025

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: 10/14/2022
• Device Model Number: 2321
• Device Catalogue Number: 2321
• Device Lot Number: 7700337
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2020
• 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 ADAPTER; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male