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

Model Number	2321
Medical Device Problem Codes	Disconnection (1171); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter phone number (b)(6).Date of event is estimated.
Event or Problem Description
It was reported that patient experienced pain at the ipg site.Reportedly, the ipg header could not secure the adapter.As a result, surgical intervention was undertaken on (b)(6) 2025, wherein the ipg was repositioned and ipg header reconnected to another adapter to address the issue.Reportedly, the disconnected adapter was explanted.
Additional Manufacturer Narrative
Corrected data.H4 - device manufacture date.D4 - additional device information, it was reported to abbott during an ipg revision to address redness at the ipg site , it was noted the lead adapter had pulled from the header of the ipg.The other adapter was intact and connected to the existing lead.One of the adapters was stuck in the ipg¿s header port.The adapter could not be removed from port 1-8.The broken adapter was explanted.The ipg was repositioned and reconnected the one lead and remaining adapter.The lead in port 9-16 was to be remapped and to await outcome if therapy was restored.On 24 may 2025 it was reported a review was conducted.It was reported the wound was not healing well and the patient was not getting adequate therapy with one lead.On 10 june 2025 it was reported the wound had still not healed and effective therapy had not been restored.No intervention has been scheduled.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
Additional Manufacturer Narrative
Corrected data.H6 - adverse event problem (refer to coding manual).
Additional Manufacturer Narrative
Corrected data: h6 - adverse event problem (refer to coding manual).

• 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: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 22136778
• Report Number: 1627487-2025-02742
• Device Sequence Number: 7445889
• Product Code: LGW
• UDI-Device Identifier: 05415067016713
• UDI-Public: (01)05415067016713(10)7630077(17)220819
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/06/2025

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: 09/08/2022
• Device Model Number: 2321
• Device Catalogue Number: 2321
• Device Lot Number: 7646602
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 07/28/2025; 08/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/16/2025; 07/28/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male