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

Patient Problems Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 02/25/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented post-cardiac arrest.The right ventricular (rv) lead was exhibiting intermittent over and undersensing, low amplitude r-wave measurements, and short ventricular intervals.Possible intermittent undersensing was observed on the right atrial (ra) lead.It was also reported that the cardiac resynchronization therapy defibrillator (crt-d) was possibly underdetecting the patient's ventricular tachycardia (vt) and ventricular fibrillation (vf).The subsequent lack of therapies was of no concern as the patient was on a do not resuscitate status.It was noted that the arrhythmias appeared to continue after they were classified as terminated by the crt-d.Detections were turned off for end of life care.The patient expired twelve days later.No further information was reported.

• 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: 9861896
• MDR Text Key: 184352173
• Report Number: 3004209178-2020-05832
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2019
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2020
• Date Device Manufactured: 04/07/2018
• 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: 6935M55 LEAD, 459888 LEAD, 5076-45 LEAD
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 68