MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

Model Number 6172

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  Injury  

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.

Event Description

Manufacturer reference number: 1627487-2020-49102.It was reported that during the implant surgery on (b)(6) 2020 the surgeon noticed that the leads were placed 1 cm short of optimal placement.As a result, both leads were replaced and procedure was completed.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 11068581
• MDR Text Key: 223588027
• Report Number: 1627487-2020-49096
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030320
• UDI-Public: 05415067030320
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 7485793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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
• Patient Outcome(s): Other
• Patient Weight: 79