MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA1QQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Seizures (2063); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Sudden Cardiac Death (2510)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was schedule for a magnetic resonance imaging (mri), but experienced a sudden cardiac arrest with arrhythmia of ventricular tachycardia (vt), ventricular fibrillation (vf), and asystole.The patient appeared to have seizure like shaking and became unresponsive prior to being placed in the imaging tube.Electrodes were then placed on the patient to monitor the heart rhythm; a code was declared, and standard life-saving procedures were administered.The cardiac resynchronization therapy defibrillator (crt-d) remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI QUAD CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10690120
• MDR Text Key: 211675223
• Report Number: 3004209178-2020-18078
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720633
• UDI-Public: 00643169720633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2021
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Date Device Manufactured: 10/17/2019
• 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: 6947M55 LEAD, 429878 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR