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

Model Number MDT-ICD

Device Problems Electromagnetic Interference (1194); Over-Sensing (1438)

Patient Problems Bradycardia (1751); Unspecified Infection (1930); Tachycardia (2095)

Event Date 12/14/2021

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) years old.Possible model numbers are listed below.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: perioperative sensor and algorithm programming in patients with implanted icds and pacemakers for cardiac resynchronization therapy.Sensors.2021, 21, 8346.Doi.Org/10.3390/s21248346 amplia mri quad crt-d dtmb2q1 amplia mri crt-d dtmbb2qq brava crt-d brava quad crt-d cardia crt-d compia mri crt-d compia mri quad crt-d concerto c174 consulta crt-p c3tr01 egida crt-d d394 trg insync 8040 insync iii 8042 insync iii marquis 7279 insync icd 7272 insync maximo 7304 protecta crt-d syncra crt-p viva quad crt-d viva xt crt-d dtba2d4.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding perioperative sensor and algorithm programming in patients with implantable cardioverter defibrillators (icd) and implantable pulse generators (ipg).The article reports patients who experienced device related tachycardia and bradycardia.There was one patient whose device was explanted and replaced due to infection.Other patients developed pacemaker syndrome which required a revision and electromagnetic interference was noted on some devices with unknown intervention.The status/disposition of the cardiac resynchronization therapy defibrillators (crt-d), crt pacemakers, and icds is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yield any additional information.

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/72 years old.Possible model numbers are listed below.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: perioperative sensor and algorithm programming in patients with implanted icds and pacemakers for cardiac resynchronization therapy.Sensors.2021, 21, 8346.Doi.Org/10.3390/s21248346 amplia mri quad crt-d dtmb2q1 amplia mri crt-d dtmbb2qq brava crt-d brava quad crt-d cardia crt-d compia mri crt-d compia mri quad crt-d concerto c174 consulta crt-p c3tr01 egida crt-d d394 trg insync 8040 insync iii 8042 insync iii marquis 7279 insync icd 7272 insync maximo 7304 protecta crt-d syncra crt-p viva quad crt-d viva xt crt-d dtba2d4.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding perioperative sensor and algorithm programming in patients with implantable cardioverter defibrillators (icd) and implantable pulse generators (ipg).The article reports patients who experienced device related tachycardia and bradycardia.There was one patient whose device was explanted and replaced due to infection.Other patients developed pacemaker syndrome which required a revision and electromagnetic interference was noted on some devices with unknown intervention.The status/disposition of the cardiac resynchronization therapy defibrillators (crt-d), crt pacemakers, and icds is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yield any additional information.

• Brand Name: MEDTRONIC ICD
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 13550235
• MDR Text Key: 285757176
• Report Number: 2182208-2022-00514
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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
• Date Manufacturer Received: 02/02/2022
• 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; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male