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

Model Number MDT-ICD

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients 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 were also not made available.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.If new information is received, a supplemental report will be submitted accordingly.Referenced article: electromagnetic interference effect of dental equipment on cardiac implantable electrical devices: a systematic review.Pace pacing clin.Electrophysiol.2020;43(12):1588-1598.Doi: 10.1111/pace.14051.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding a meta-analysis of electromagnetic interference effect of dental equipment on cardiac implantable electrical devices.It was reported that an unspecified number of implantable pulse generators (ipgs) were noted to exhibit electromagnetic interference with the use of various dental equipment.Noise, pacing, and telemetry issues were also observed in some cases.Additionally, electromagnetic interference and noise were noted with the use of implantable cardioverter defibrillators (icds).In some cases, the settings were reprogrammed and the devices remain in use.No patient complications have been reported as a result of these events.

• Brand Name: MEDTRONIC ICD
• 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: 11566003
• MDR Text Key: 242160429
• Report Number: 2182208-2021-01179
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/24/2021

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-ICD
• Device Catalogue Number: MDT-ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/24/2021
• 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): Required Intervention