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 Pacing Problem (1439)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 6935m62, lead, implanted: (b)(6) 2020.40025, tissue valve, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that by the patient that they felt like they have been "out of rhythm" for the past two weeks.The patient noted that their heart rate with their blood pressure monitor was forty and they were told by the physician that the device was programmed not to go below sixty.The patient also had concerns of their heart being irregular.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: 10945496
• MDR Text Key: 219548425
• Report Number: 3004209178-2020-21139
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2021
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/04/2020
• Date Device Manufactured: 11/25/2019
• 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: 407652 LEAD, 429888 LEAD
• Patient Age: 74 YR