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

Model Number	3244
Medical Device Problem Codes	Therapeutic or Diagnostic Output Failure (3023); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's lead had migrated.As a result, the patient underwent surgical intervention during which the lead was explanted and replaced.Effective therapy was established post-operatively.
Additional Manufacturer Narrative
Date of event is estimated.Initial reporter phone number:(b)(6) 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.
Event or Problem Description
It was reported that the patient was experiencing ineffective therapy due to the leads being placed at another level.As a result, the patient underwent surgical intervention during which the lead was explanted and replaced.Effective therapy was established post-operatively.
Additional Manufacturer Narrative
A patient experiencing lead migration was reported to abbott.The patient¿s lead was replaced.Therapy was restored.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.

• 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: 18584059
• Report Number: 1627487-2024-00414
• Device Sequence Number: 8517292
• Product Code: LGW
• UDI-Device Identifier: 05414734402071
• UDI-Public: 05414734402071
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 06/07/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: 3244
• Device Lot Number: 8049787
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 06/06/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/12/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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