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

Model Number MDT

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Protective Measures Problem (3015)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The overall baseline gender characteristics is male; the age of the patients was approximately 60 years old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The model listed in the report is a representative of the model manufacturer, as 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: "patient perspective and safety of remote monitoring of implantable cardioverter-defibrillators in the polish nationwide multicenter registry: medtronic ¿carelink¿ network evaluation." polish cardiology.2020.Doi: 10.33963/kp.15556.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding the patient perspective and safety of remote monitoring of implantable cardioverter-defibrillators.The article reports instances of electromagnetic interference, inappropriate discharge and detection, and device alerts which required hospitalization, reprogramming, medication changes, and further observation.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: 10755925
• MDR Text Key: 213689595
• Report Number: 2182208-2020-02577
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT
• Device Catalogue Number: MDT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 10/29/2020
• 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
• Patient Age: 60 YR