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

Model Number 6371

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

Patient Problem Implant Pain (4561)

Event Date 10/17/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The allegation is against 1 of 2 lead extensions; however, it is unknown which lead extension, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: 8ch infinity coiled ext kit, 50cm, clear, model: 6173, udi:(b)(4), serial:(b)(6), batch: 6192223.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.

Event Description

Related manufacturer report number: 1627487-2023-05288.It was reported that the patient experienced discomfort at the ipg site and the extensions by the neck/ear area.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein ipg pocket site in the chest area was revised.It is unknown which lead extension was liable.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B
• Type of Device: DBS LEAD 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: 18091740
• MDR Text Key: 327617047
• Report Number: 1627487-2023-05290
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020307
• UDI-Public: 05415067020307
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: 6371
• Device Lot Number: 6174238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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 (2); DBS LEAD (2); DBS LEAD EXTENSION
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 79 KG