MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number	3219
Medical Device Problem Codes	Use of Device Problem (1670); Impedance Problem (2950)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient lead was abandoned and left implanted during a system revision on (b)(6) 2022.No intervention is planned to retrieve the lead.
Additional Manufacturer Narrative
Correction: section h6 - the medical device problem code should have been 2950 impedance problem rather than 1670 - use of device problem.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: LAMITRODE TRIPOLE 16 LEAD, 60 CM
• Common Device Name: SCS 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: 15937244
• Report Number: 1627487-2022-06628
• Device Sequence Number: 20443541
• Product Code: LGW
• UDI-Device Identifier: 05415067017628
• UDI-Public: 05415067017628
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 03/03/2023

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: 03/28/2012
• Device Model Number: 3219
• Device Catalogue Number: 3219
• Device Lot Number: 3094246
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 01/20/2023; 02/13/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/24/2023; 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2010
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 77 KG