MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

Model Number 6173

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

Patient Problems Paresis (1998); Movement Disorder (4412)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-14962.It was reported the patient experienced right side facial droop and dysarthria immediately following dbs lead implant procedure.Scans did not show signs of stroke.Both the dysarthria and facial droop have improved without intervention.

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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device, patient and event information.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B
• Type of Device: DBS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12028263
• MDR Text Key: 257154193
• Report Number: 1627487-2021-14961
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020697
• UDI-Public: 05415067020697
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: 6173
• Device Catalogue Number: 6173
• Device Lot Number: 7108770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 6173, DBS LEAD
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 87