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

Model Number 6371

Device Problem Impedance Problem (2950)

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

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.(b)(6).He event of ipg and extension replacement was reported to abbott.The ipg and extension was explanted and replaced due to a connection issue.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2023-04849, 1627487-2023-04852.It was reported that the patient had trouble connecting their ipg to external devices, the connection being unstable when connected.Additionally, multiple contacts showed as out of range.Surgical intervention took place wherein the ipg and extensions were explanted and replaced to address the issue.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 50CM, B
• Type of Device: DBS EXT
• 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: 17911558
• MDR Text Key: 325373738
• Report Number: 1627487-2023-04851
• 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
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2021
• Device Model Number: 6371
• Device Lot Number: 7301970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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