MAUDE Adverse Event Report: MEDTRONIC, INC. INSYNC SENTRY; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 7298

Device Problem Reset Problem (3019)

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

Event Date 07/01/2019

Event Type  malfunction  

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.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: radiation therapy induced dysfunction in cardiovascular implantable electronic devices.Practical radiation oncology (2019) 9, 266-273.Doi.Org/10.1016/j.Prro.2019.03.003.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding this radiation therapy induced dysfunction in cardiovascular implantable electronic devices (cied).The article reports patients whose implantable cardioverter defibrillators (icd) exhibited power on resets (por) and leads which exhibited increased atrial thresholds.The status/ disposition of the devices and leads appears to be still in use.No patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• Brand Name: INSYNC SENTRY
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 11779444
• MDR Text Key: 249208174
• Report Number: 2182208-2021-01830
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010031
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7298
• Device Catalogue Number: 7298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• 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 Age: 77 YR