MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION

Model Number	3346
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2022-06694.It was reported the patient is not receiving effective therapy due to high impedances.X-rays indicated there was a fracture in the splitter.Surgical intervention is planned to address the issue.
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.
Event or Problem Description
Additional information was received wherein the extensions were explanted and replaced and effective therapy was established.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 60CM
• Common Device Name: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15949028
• Report Number: 1627487-2022-06693
• Device Sequence Number: 17977172
• Product Code: LGW
• UDI-Device Identifier: 05414734402309
• UDI-Public: 05414734402309
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/20/2023

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: 01/28/2016
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 4413940
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 02/05/2023; 04/17/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 02/05/2023; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• 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; SCS LEADX4
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 98 KG