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

Model Number 6371

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 12/12/2022

Event Type  Injury  

Event Description

It was reported during ipg replacement, the lead extension appeared fractured as the physician struggled to advance the extension into the header.Intra-op diagnostics measured high impedances.Multiple attempts were made to clear the impedances using the lead and extension insertion tool.The extension was inserted into the port measuring high impedances on one contact.Effective therapy was restored post-operatively.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively 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: 16070908
• MDR Text Key: 306361639
• Report Number: 1627487-2022-07145
• Device Sequence Number: 1
• Product Code: MHY
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2020
• Device Model Number: 6371
• Device Catalogue Number: 6371
• Device Lot Number: 6509939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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
• Patient Sex: Male
• Patient Weight: 84 KG