MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LEAD; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number MDT-LEAD

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

Patient Problem Unspecified Infection (1930)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

A voluntary medwatch form 3500 was received (report #mw5151393); since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.F1 user facility f2 uf/importer report number: f3 user facility name/address: f4 contact person: f5 phone number: f6 date user facility became aware of the event: f7 type of report: version -1 f8 date of this report: 18-jan-2024.F9 approximate age of device: f10 event problem codes: f11 report sent to fda: n f12 location where event occurred: f13 report sent to manufacturer: f14 manufacturer name and address: mfr.Name: medtronic.Address: (b)(6).City: (b)(6).State: (b)(6).Zip: (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that developed a pocket infection.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted.No further patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC LEAD
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18966379
• MDR Text Key: 338434064
• Report Number: 2182208-2024-01247
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MDT-LEAD
• Device Catalogue Number: MDT-LEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• 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): Hospitalization; Required Intervention