MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

Model Number	6173
Medical Device Problem Codes	Therapeutic or Diagnostic Output Failure (3023); Migration (4003)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter phone number (b)(6).Date of event is estimated.
Event or Problem Description
It was reported that patient experienced involuntary movement.Repositioning the lead on (b)(6) 2023 did not resolve the issue.It was confirmed via ct-scan that the left lead had migrated.As a result, surgical intervention was undertaken wherein the lead was explanted to address the issue.
Additional Manufacturer Narrative
Corrected data describe event or problem date of explant a patient underwent a lead revision was reported to abbott.It was determined that after a lead explant due to involuntary movement a new lead was implanted, and patient¿s symptoms persisted.Ct-scan showed that the newly implanted lead had migrated.As a result, the lead was explanted to address the issue.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
It was reported that patient experienced involuntary movements of the right upper extremity.Surgical intervention was undertaken on (b)(6) 2023 wherein the left lead was explanted and replaced.The involuntary movements of the right upper extremity persisted after the replacement.Cranial ct-scan showed that the newly implanted left lead had migrated.As a result, surgical intervention was undertaken on 22 mar 2024 wherein the left lead was explanted to address the issue.
Additional Manufacturer Narrative
A patient underwent a lead revision was reported to abbott.It was determined that after a lead explant due to involuntary movement a new lead was implanted, and patient¿s symptoms persisted.Ct-scan showed that the newly implanted lead had migrated.As a result, the lead was explanted to address the issue.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.
Additional Manufacturer Narrative
A patient underwent a lead revision was reported to abbott.It was determined that after a lead explant due to involuntary movement a new lead was implanted, and patient¿s symptoms persisted.Ct-scan showed that the newly implanted lead had migrated.As a result, the lead was explanted to address the issue.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: 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B
• Common Device Name: DBS 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: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19016501
• Report Number: 1627487-2024-07868
• Device Sequence Number: 20876124
• Product Code: MHY
• UDI-Device Identifier: 05415067020697
• UDI-Public: (01)05415067020697(10)5517880(17)180531
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 09/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 6173
• Device Lot Number: 5517880
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/05/2024; 03/27/2025; 08/26/2025
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/29/2024; 03/28/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2016
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 73 KG