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

Model Number 6172

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-17109.Related manufacturer reference number: 1627487-2021-19357.It was reported that the patient's leads were explanted on an unknown date for an unknown reason.

Manufacturer Narrative

There were no reported allegations against the returned lead b.Analysis of the returned lead found it was cut during the explant procedure and only the terminal end segment was returned.There were set screw engagement marks on the appropriate contact on the terminal end indicating the lead was properly inserted.During processing of this incident, attempts were made to obtain complete patient and event information.

• 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: 13101853
• MDR Text Key: 282911094
• Report Number: 1627487-2021-19358
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2021
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 6902176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female