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

Model Number DTMA1QQ

Device Problem Pacing Problem (1439)

Patient Problems Nausea (1970); Tachycardia (2095)

Event Date 07/04/2019

Event Type  Death  

Manufacturer Narrative

(b)(4) database report number: mw5101588.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by a patient family member that the patient is deceased.Prior to their death the patient experienced nausea while on vacation and presented to the hospital after returning home.The patient was noted to be in ventricular tachycardia (vt) which had been occurring for three days.It was reported that the ¿device failed to pace¿ the patient¿s heart into a ¿normal rhythm and¿ was unable to reset the rhythm.The device was noted to eventually slow the heart rate but ¿all this maneuvering put undue stress¿ on the heart.Medication adjustments were made, and the patient was discharged.The patient had two additional hospitalizations for vt and during the last stay an ablation procedure was performed and medication adjustments continued including adjustments to control the creatinine level.It was additionally reported that the device made a high-pitched siren sound while in use and the physician office turned off the alert.The patient¿s family also reported that the patient¿s device was ¿defective¿.The patient is reported to have later passed away ¿from the damaged caused to ¿the patient¿s heart as the patient was in vt for three days.

• Brand Name: CLARIA MRI QUAD CRT-D SURESCAN
• 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: 12264103
• MDR Text Key: 264687404
• Report Number: 2182208-2021-03043
• Device Sequence Number: 1
• Product Code: NIK
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2021

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 Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/02/2021
• 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 Outcome(s): Death