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

Model Number 6371

Device Problem Material Twisted/Bent (2981)

Patient Problem Implant Pain (4561)

Event Date 04/04/2023

Event Type  Injury  

Event Description

Related manufacturer reference numbers: 1627487-2023-01991 and 1627487-2023-01993.It was reported that the patient's ipg migrated in the pocket, causing discomfort and twisting of the extensions.Surgical intervention was undertaken in which sutures were added to secure the ipg and the extensions were explanted and replaced to address the issue.

Manufacturer Narrative

Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16841382
• MDR Text Key: 314262440
• Report Number: 1627487-2023-01992
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030344
• UDI-Public: 05415067030344
• 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
• Report Date: 04/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6371
• Device Catalogue Number: 6371
• Device Lot Number: 8557654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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 LEAD (X2)
• Patient Sex: Female
• Patient Weight: 91 KG