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

Model Number 6371

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-05929,1627487-2023-05930.It was reported the patient's leads had high impedances.Surgical intervention was undertaken wherein the ipg and extensions were explanted and replaced to address the issue.

Manufacturer Narrative

Date of event is estimated.E1: (b)(6).

Manufacturer Narrative

The report of high impedance was confirmed.Analysis of extension a found it had broken wires and multiple opens when tested for continuity.These fractures are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18376371
• MDR Text Key: 331133565
• Report Number: 1627487-2023-05931
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020307
• UDI-Public: 05415067020307
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: 6371
• Device Lot Number: 7199894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• 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
• Patient Outcome(s): Other