MAUDE Adverse Event Report: ABBOTT MEDICAL 8-CHANNEL ADAPTER, BSX, 60CM; SCS EXTENSION

Model Number	2326
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference manufacturer number: 1627487-2020-47658.It was reported that there were high impedances on the scs lead adapter that was noticed during the ipg replacement surgery.In turn, the patient underwent surgical intervention to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.Attempts were made to obtain complete event and patient information.Additional information was not provided.A system displaying warning message ¿replace generator¿ was reported to abbott.The implant was subsequently replaced by physician.The results of the investigation are inconclusive since the device nor logs or settings were returned for analysis.Based on the information received, the cause of the reported incident is consistent with the ipg reaching end of life.

• Brand Name: 8-CHANNEL ADAPTER, BSX, 60CM
• Common Device Name: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11368871
• Report Number: 1627487-2021-01570
• Device Sequence Number: 858324
• Product Code: LGW
• UDI-Device Identifier: 05415067016140
• UDI-Public: 05415067016140
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 2326
• Device Catalogue Number: 2326
• Device Lot Number: 5524356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL 3660, SCS IPG