MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B; DBS LEAD EXTENSION

Model Number 6371

Device Problem High impedance (1291)

Patient Problem Movement Disorder (4412)

Event Date 01/29/2024

Event Type  Injury  

Event Description

Related manufacturer report number: 1627487-2024-07059, 1627487-2024-07061.It was reported that the patient's lead had high impedances.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein both patient's extensions and ipg were explanted and replaced to address the issue.Effective therapy was restored as well as high impedances resolved post-op.

Manufacturer Narrative

Date of event is estimated.Information requested, but not yet received.

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete patient information.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.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B
• Type of Device: DBS LEAD EXTENSION
• 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: 18742615
• MDR Text Key: 335785418
• Report Number: 1627487-2024-07060
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2019
• Device Model Number: 6371
• Device Lot Number: 6026685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DBS BURR HOLE CAP (2); DBS LEAD (2)
• Patient Outcome(s): Other
• Patient Sex: Male