MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

Model Number 6173

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.

Event Description

It was reported the patient's lead was not where it should be, it is unknown if the lead migrated or was not placed properly.Surgical intervention was undertaken during which the existing lead was explanted and replaced to address the issue.

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.

Manufacturer Narrative

Corrected data: health effect code has been changed from 2388 - inadequate pain relief to 4582 - no clinical signs, symptoms or conditions and 4610 - inadequate/inappropriate treatment or diagnostic exposure has been removed.

Manufacturer Narrative

Corrected data: medical device problem code: 2993 - adverse event without identified device or use problem to: 1670 - use of device problem.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B
• Type of Device: DBS LEAD
• 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: 15764783
• MDR Text Key: 303389442
• Report Number: 1627487-2022-05768
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030337
• UDI-Public: 05415067030337
• 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,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: 6173
• Device Catalogue Number: 6173
• Device Lot Number: 7995771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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.; DBS BURR HOLE CAP.; DBS LEAD.
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 73 KG