MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 44 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3244
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-18476.It was reported one of the patient¿s leads eroded through the skin.Surgical intervention took place wherein the lead was explanted.It is unknown which lead was explanted, as such both leads are being reported.
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 received indicates surgery took place on (b)(6) 2022 wherein the second lead was explanted due to the lead eroding through the skin.The system was replaced.The ipg was electively replaced.

• Brand Name: LAMITRODE 44 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• 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: 12840440
• Report Number: 1627487-2021-18477
• Device Sequence Number: 4546781
• Product Code: LGW
• UDI-Device Identifier: 05414734402071
• UDI-Public: 05414734402071
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/18/2022

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: 12/12/2021
• Device Model Number: 3244
• Device Catalogue Number: 3244
• Device Lot Number: 7301948
• 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: 11/02/2021
• Supplement Date Received by Manufacturer: 01/18/2022; 02/04/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 01/18/2022; 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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 ADAPTERS X 2; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 64 KG