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 Hematoma (1884); Unspecified Infection (1930); Pneumothorax (2012)

Event Date 01/01/2021

Event Type  Injury  

Event Description

A journal article was reviewed that contained information regarding epicardial and endocardial pacemakers in pediatric groups.The article reports three post implantation complications; one patient with an epicardial implantable pulse generator (ipg) developed a pocket infection after one month and had to receive a new device system, one patient experienced a pneumothorax during venous access, which was treated conservatively, and one patient developed a pocket hematoma which was subsequently evacuated.There were lead failures with interventions which included right ventricular (rv) lead and right atrial (ra) lead displacements, twiddler¿s syndrome, fractures, high thresholds, and insulation breaks.The status/disposition of the devices and leads is unknown.No further patient complications have been reported as a result of this event.

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 female/(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: epicardial versus endocardial pacemakers in the pediatric population: a comparative inquiry.Congenital heart disease.2021.Vol.16, no.6.Doi: 10.32604/chd.2021.016271.If information is provided in the future, a supplemental report will be issued.

• 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: 14647311
• MDR Text Key: 293720405
• Report Number: 2182208-2022-01888
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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: 06/09/2022

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: 06/09/2022
• 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 LEADS.
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 5 YR
• Patient Sex: Female