MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

Model Number 6172

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cognitive Changes (2551); Swelling/ Edema (4577)

Event Date 06/20/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2022-04326.It was reported the patient experienced a decline in cognition and bladder problems post dbs implant.Patient was hospitalized due to bladder infection and placed on oral antibiotics.An mri was ordered and indicated edema around the implanted leads, reportedly.It is unknown if the edema is contributing to the issues.Therapy remains on, however patient's health has declined and it is unknown if dbs therapy is effective.Lead diagnostics and programming was performed.Additional imaging and physical therapy is pending to address the issue.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event information.Further information was requested but not received.A patient experiencing issues post dbs implant was reported to abbott.No updates.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.Please note this report submission is not late.The report is resubmitted per the request from the fda, due to missing 3rd acknowledgement.This is caused by an fda esg server issue from september 21 ¿ 23, 2022.This issue is documented in helpticket (b)(4).The initial submission attempt was performed on 23 september 2022.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B
• Type of Device: 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15213711
• MDR Text Key: 297742582
• Report Number: 1627487-2022-04327
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030320
• UDI-Public: 05415067030320
• 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: 10/19/2022

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: 07/29/2023
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 8070392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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 EXTENSION X2; DBS IPG
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male