MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B; EXTENSION

Model Number 6373

Device Problems Fracture (1260); Impedance Problem (2950)

Patient Problems Failure of Implant (1924); Movement Disorder (4412)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

B3-date of event is estimated.

Event Description

Related manufacturer report number 1627487-2024-07386 and 1627487-2024-07387 it was reported the device displayed the elective replacement indicator message and it is unknown if the device depleted prematurely.Prior to the surgery it was discovered the extensions had impedances.As a result, surgical intervention was undertaken the ipg, and extensions was explanted and replaced.Effective therapy was restored post operatively.

Manufacturer Narrative

The report of high impedance was confirmed.Analysis of extension b found when testing the stimulation end segment for continuity all channels were ¿open¿.The fractures (opens) are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B
• Type of Device: 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: 18866955
• MDR Text Key: 337231514
• Report Number: 1627487-2024-07388
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020864
• UDI-Public: 05415067020864
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 6373
• Device Lot Number: 5872380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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 (X2); DBS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 71 KG