MAUDE Adverse Event Report: ABBOTT MEDICAL KIT TRIAL SLIM TIP LEAD, 50CM; DRG TRIAL SLIM TIP LEAD

Model Number MN10350-50A

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer report number 1627487-2022-06913.It was reported patient had an infection at trial leads site.The patient's leads were explanted on (b)(6) 2022 and the patient has been treated for infection.

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.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the lead site(s), however, no explanted products were returned for analysis.The patient has been treated for infection.As a result, a device history record was performed to review and confirm the sterility of the lead(s).Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 50CM
• Type of Device: DRG TRIAL SLIM TIP 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: 16000011
• MDR Text Key: 305680988
• Report Number: 1627487-2022-06914
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027139
• UDI-Public: 05415067027139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: 8583621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 02/06/2023; 02/15/2024
• Supplement Dates FDA Received: 02/14/2023; 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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; Hospitalization
• Patient Sex: Male
• Patient Weight: 77 KG