MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number MDT-IPG

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

Patient Problems Endocarditis (1834); Hematoma (1884); Unspecified Infection (1930); Pneumothorax (2012); Cardiac Tamponade (2226); Pericardial Effusion (3271); Syncope/Fainting (4411); Respiratory Arrest (4461)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/(b)(6).The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: implantation of cardiac electronic devices in active covid-19 patients: results from an international survey.Heart rhythm.2022; 19:206¿216.Doi: 10.1016/j.Hrthm.2021.10.020.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding implantation of cardiovascular implantable electronic devices (cied) in active covid-19 patients.The article reports patients who experienced pneumothorax, pericardial effusions, respiratory arrest and periprocedural intubation, significant pocket hematomas which were treated conservatively, mild pocket infection that was treated with antibiotic therapy, syncope with left bundle branch block, early right ventricular (rv) lead dislodgment which required repositioning, cardiac tamponade after repositioning which required urgent percutaneous drainage, right atrial (ra) lead dislodgment which required repositioning, lead revision due to lead noise with inappropriate shock, and one pacemaker-dependent patient who underwent device extraction due to infective endocarditis and was later reimplanted with a single chamber device.The status/ disposition of the leads and devices is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• Brand Name: MEDTRONIC IPG
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 14637473
• MDR Text Key: 293715224
• Report Number: 2182208-2022-01870
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2022

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: Lay User/Patient
• Device Model Number: MDT-IPG
• Device Catalogue Number: MDT-IPG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/08/2022
• 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
• Treatment: UNKNOWN COMPETITOR LEADS.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male