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

Model Number 6372

Device Problem Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/27/2023

Event Type  Injury  

Event Description

Related manufacturer reference number 1627487-2023-01304.It was reported the patient experienced ineffective therapy.Diagnostics indicated that the leads had multiple contacts with low and high impedance.Surgical intervention was undertaken where in the extension was explanted and replaced restoring therapy.

Manufacturer Narrative

B3-date of event is estimated.

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 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: 16921609
• MDR Text Key: 315118301
• Report Number: 1627487-2023-02153
• 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,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 6800156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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
• Treatment: DBS BURR HOLE CAP (X2); DBS EXTENSION; DBS LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 93 KG