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

Model Number MDT-UNKNOWN

Device Problems Failure to Charge (1085); Impedance Problem (2950); Protective Measures Problem (3015); Reset Problem (3019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

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 lot/serial numbers.There is no specific model listed.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: "cardiac implantable electronic device remote monitoring in a large cohort of patients and the need of planning." future cardiology.2020.Doi: 10.2217/fca-2019-0039.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding cardiac implantable electronic device remote monitoring.The article reports patients who received alerts for electrical resets, charge circuit timeouts, excessive charge time with end of service, and ventricular defibrillation impedance out of range which required hospitalizations and/or reprogramming.The status/disposition of the 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
• Type of Device: PULSE-GENERATOR, PACEMAKER, 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: 10757960
• MDR Text Key: 214086073
• Report Number: 2182208-2020-02591
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-UNKNOWN
• Device Catalogue Number: MDT-UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• 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