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

Model Number 6371

Device Problems Break (1069); Disconnection (1171); High impedance (1291)

Patient Problems Inadequate Pain Relief (2388); Movement Disorder (4412)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer report number: 3006705815-2024-01606.It was reported that the patient had high impedances on the left lead.It was noted that the patient had a fall.Reprogramming was unable to resolve the issue.X-rays were done and it seemed on the ipg end the left extension was out a little.In a recent update it was reported that the extension was damaged.As a result, surgical intervention was undertaken on 21feb2024 wherein the left extension was explanted and replaced to address the issue.Effective therapy was restored post-op with no impedance issues.

Manufacturer Narrative

Correction: section h6: the health effect code should have been 4412-movement disorder rather than 2388 - inadequate pain relief.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, 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18813600
• MDR Text Key: 336616678
• Report Number: 1627487-2024-07254
• 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: 03/21/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 6371
• Device Lot Number: 9026059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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 CAP (2).; DBS EXTENSION (1).; DBS LEAD (2).
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 68 KG