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

Model Number	2321
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 3006705815-2024-00801.It was reported that the patient was experiencing ineffective therapy and pocket stimulation.Surgical intervention was undertaken to explant and replace the system.Effective therapy was established postoperatively.The allegation is against 1 of 2 adapters; however, it is unknown which adapter, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: bsx adapter, model: 2321ans, udi: (b)(4), serial: (b)(6), batch: 7297399.
Additional Manufacturer Narrative
Date of event is estimated.The allegation is against 1 of 2 adapters; however, it is unknown which adapter, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: bsx adapter, model: 2321ans, udi: (b)(4), serial: (b)(6), batch: 7297399.
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation.The pocket stimulation was resolved.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: 8-CHANNEL ADAPTER, BSX, 10CM
• Common Device Name: SCS LEAD 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: 18603746
• Report Number: 1627487-2024-00516
• Device Sequence Number: 9128437
• Product Code: LGW
• UDI-Device Identifier: 05415067016713
• UDI-Public: 05415067016713
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 02/14/2024

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: 10/20/2021
• Device Model Number: 2321
• Device Catalogue Number: 2321
• Device Lot Number: 7224954
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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 ADAPTER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 100 KG