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 Problems Inadequate Pain Relief (2388); Twiddlers Syndrome (4563)

Event Date 01/19/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Manufacturer report number 1627487-2023-00717.It was reported the patient was twiddling and rotating the ipg in the pocket site causing the extension to twist.The patient experienced ineffective stimulation to due impedance issues.Surgical intervention took place on 14 april 2023 wherein the extension was explanted, replaced and the same ipg was used and placed in the same pocket site.Effective stimulation was restored post-op.

Manufacturer Narrative

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.

• 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: 16897376
• MDR Text Key: 314853093
• Report Number: 1627487-2023-02165
• 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: 07/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 8278878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 82 KG