MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL CLARIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA1D1

Device Problems Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095)

Event Date 01/20/2022

Event Type  Injury  

Event Description

It was reported that the patient was pulseless, in ventricular tachycardia (vt), and the cardiac resynchronization therapy defibrillator (crt-d) didn't shock the patient as the device classified the rhythm as non-sustained ventricular tachycardia. a possible detection reset by the device discriminator used to distinguish between rapid and gradual onset of fast ventricular rhythms was noted and may have contributed to therapy not being delivered. cardiopulmonary resuscitation was performed and the device remains in use. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: CLARIA MRI CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13416470
• MDR Text Key: 284817290
• Report Number: 9614453-2022-00309
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059552
• UDI-Public: 00763000059552
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2022

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 Expiration Date: 12/28/2022
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/01/2022
• Date Device Manufactured: 07/05/2021
• 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
• Treatment: 383069 LEAD (X2), 694765 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 89 KG