MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION

Model Number 6372

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/22/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced a loss of therapy approximately two weeks ago due to their lead extension being fractured.The fractured extension resulted in high impedances.Surgical intervention was taken to replace the lead.Issue has been resolved.

Manufacturer Narrative

Date of event is estimated.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 incident could not be conclusively determined.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 60CM, 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: 15573524
• MDR Text Key: 301482844
• Report Number: 1627487-2022-05369
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030351
• UDI-Public: 05415067030351
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 6754073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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
• Treatment: BURR HOLE COVER; DBS IPG; DBS LEAD
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 79 KG