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

Model Number	2326
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-14387.It was reported the patient experienced ineffective stimulation due to high impedances.Surgical intervention may take place at a later date.
Additional Manufacturer Narrative
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 incident could not be conclusively determined.
Additional Manufacturer Narrative
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 incident could not be conclusively determined.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.
Event or Problem Description
Additional information received indicates the patients adapters were explanted to resolve the issue.

• 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: 11876935
• Report Number: 1627487-2021-14388
• Device Sequence Number: 3560271
• Product Code: LGW
• UDI-Device Identifier: 05415067016140
• UDI-Public: 05415067016140
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/31/2021

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: 04/02/2021
• Device Model Number: 2326
• Device Catalogue Number: 2326
• Device Lot Number: 6920659
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 07/25/2021; 08/31/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/23/2021; 08/12/2021; 08/31/2021
• 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 2321 ADAPT; MODEL 2321 ADAPT
• Outcome Attributed to Adverse Event: Other