MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B; LEAD EXTENSION

Model Number 6373

Device Problem High impedance (1291)

Patient Problems Inadequate Pain Relief (2388); Movement Disorder (4412)

Event Date 01/09/2024

Event Type  Injury  

Event Description

Related manufacturer reference number 1627487-2024-00326.It was reported the extensions were replaced due to high impedance and fracture.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

The reported high impedance was not confirmed.As received, the continuity testing showed the returned both end segments of lead (b) passed isolation resistant testing.The cause of the reported event is due to damage during use.

Manufacturer Narrative

H6 - adverse event problem - the clinical codes were corrected to reflect dbs patient symptoms.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B
• Type of Device: 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: 18631225
• MDR Text Key: 334435666
• Report Number: 1627487-2024-00327
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020864
• UDI-Public: 05415067020864
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Model Number: 6373
• Device Lot Number: 5664685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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: 6172.; 6172.; 6662.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 77 KG