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

Model Number	2321
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ipg repositioning on (b)(6)2025, (related manufacturer reference number 3006705815-2025-01926), the physician was unable to advance the adapters because they were pliable.As a result, the adapters were explanted and replaced to address the issue.
Additional Manufacturer Narrative
The event of pliable bsx adapters was reported to abbott.During a pocket revision, the ipg was relocated due to significant weight loss.When attempting to plug in bsx adapters they were too pliable to insert into battery header.Issue resolved with new bsx adapters.Therapy restored post-op.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.

• Brand Name: 8-CHANNEL ADAPTER, BSX, 10CM
• Common Device Name: SCS ADAPTERS
• 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: 21627552
• Report Number: 1627487-2025-01296
• Device Sequence Number: 18225508
• Product Code: LGW
• UDI-Device Identifier: 05415067016713
• UDI-Public: (01)05415067016713(10)7129939(17)210912
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: 09/12/2021
• Device Model Number: 2321
• Device Catalogue Number: 2321
• Device Lot Number: 7129939
• 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: 03/05/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2019
• 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 IPG.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 68 KG