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

Model Number	3244
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing ineffective therapy.It was noted that their lead had high impedances on all contacts.As a result, the patient may undergo surgical intervention to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.Initial reporter phone number: (b)(6).
Additional Manufacturer Narrative
A patient experienced ineffective therapy was reported to abbott.It was also determined the lead had high impedances on all contacts.No intervention is scheduled at this time.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 event could not be conclusively determined.
Event or Problem Description
Additional information received identified that patient underwent surgical intervention wherein, the lead was explanted and replaced.Effective therapy was restored post operatively.
Additional Manufacturer Narrative
The report event of high impedances was confirmed.As received, microscopic inspection showed the returned lead found all the internal lead wires broken.

• Brand Name: LAMITRODE 44 LEAD KIT, 60CM LENGTH
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20276284
• Report Number: 1627487-2024-11081
• Device Sequence Number: 7240271
• Product Code: LGW
• UDI-Device Identifier: 05414734402071
• UDI-Public: (01)05414734402071(10)8783783(17)241130
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/10/2025

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: 11/30/2024
• Device Model Number: 3244
• Device Catalogue Number: 3244
• Device Lot Number: 8783783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 11/21/2024; 01/07/2025
• Initial Report FDA Received Date: 09/22/2024
• Supplement Report FDA Received Date: 10/14/2024; 12/10/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown