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 Problems Death (1802); Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.During the processing of this incident, attempts were made to obtain complete event information.

Event Description

Related manufacturer report number: 1627487-2020-47903.It was reported that the patient's health was declining after a dbs lead implant procedure.

Manufacturer Narrative

Date of death is unknown.

Event Description

Additional information received indicates that the patient had passed away on an unknown date.No further information is available at this time.

Event Description

Additional information received indicates that the patient had a brain bleed that was detected several days after surgery, possibly after discharge.An obituary states that the patient passed away after an extended illness.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Correction: section a date of birth should have been (b)(6), 1961 instead of (b)(6) 1961 in the initial report.This correction is reflected in this additional report 2.

• 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
• MDR Report Key: 10872174
• MDR Text Key: 217298243
• Report Number: 1627487-2020-47904
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030320
• UDI-Public: 05415067030320
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 7439659
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DBS LEAD; DBS LEAD
• Patient Outcome(s): Other
• Patient Weight: 91