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

Model Number	3245
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced ineffective therapy.Troubleshooting revealed that the lead was fractured.As a result surgical intervention may be undertaken at a later date.
Additional Manufacturer Narrative
Date of event is estimated.
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 during processing of this incident, attempts were made to obtain complete patient information.
Additional Manufacturer Narrative
Date of event estimated.
Event or Problem Description
Additional information was received stating surgical intervention took place where the entire system was explanted and replaced to address the issue.Per the patient's and physician decision.Effective stimulation was restored.
Additional Manufacturer Narrative
G3: has been corrected from oct 28, 2022 to oct 28, 2024.
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: LAMITRODE 44C 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16287081
• Report Number: 1627487-2023-00499
• Device Sequence Number: 14642006
• Product Code: LGW
• UDI-Device Identifier: 05414734402088
• UDI-Public: 05414734402088
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 11/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 3245
• Device Catalogue Number: 3245
• Device Lot Number: 3595475
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 03/19/2023; 08/01/2024; 10/28/2022; 10/28/2024
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/31/2023; 08/26/2024; 11/10/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2012
• 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 ANCHOR (X2).; SCS IPG.; SCS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 68 KG