MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION

Model Number 6372

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  Injury  

Event Description

It was reported that the patient's system diagnostics recorded high impedances on the extensions.Surgical intervention may take place at a future date to address the issue.

Manufacturer Narrative

Date of event estimated.

Manufacturer Narrative

Date of event estimated.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

Manufacturer Narrative

Date of event estimated.

Event Description

Additional information was received stating that surgical intervention took place where the extension was explanted and replaced to address the issue.The ipg was electively replaced.

Manufacturer Narrative

Date of event estimated.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 60CM, 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: 19006778
• MDR Text Key: 338943614
• Report Number: 1627487-2024-07821
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020857
• UDI-Public: 05415067020857
• 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,Followup,Followup
• Report Date: 07/24/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: 6372
• Device Lot Number: 6351459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/10/2024; 04/04/2024; 06/26/2024
• Supplement Dates FDA Received: 04/16/2024; 04/25/2024; 07/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2018
• 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 HOLD CAP; DBS IPG; DBS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 45 KG