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

Model Number 6371

Device Problems Impedance Problem (2950); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Movement Disorder (4412); Twiddlers Syndrome (4563)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2023-04910.It was reported diagnostic revealed that the system impedance were fluctuating and showing low and high impedances.Reportedly the patient is a twiddler and twisted the extensions.As such, surgical intervention took place wherein the extensions were explanted and replaced to address the issue.Reportedly, the issue was resolved and therapy was confirmed post operatively.

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.

Manufacturer Narrative

Corrected data: medical device problem code.

Event Description

Additional information received indicates that the extensions were frayed due to the patient twisting them.

Manufacturer Narrative

Corrected data: medical device problem code - changed from 2981 - material twisted/bent to 2993 - adverse event without identified device or use problem.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B
• Type of Device: DBS 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: 17936875
• MDR Text Key: 325675821
• Report Number: 1627487-2023-04911
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020307
• UDI-Public: 05415067020307
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: 6371
• Device Lot Number: 6994803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/15/2023
• Supplement Dates Manufacturer Received: 09/21/2023; 10/30/2023; 10/30/2023
• Supplement Dates FDA Received: 10/18/2023; 10/31/2023; 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2019
• 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 (X2); DBS IPG; DBS LEAD (X2)
• Patient Outcome(s): Other