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 Ventricular Tachycardia (2132); Syncope/Fainting (4411)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-52, lead, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was in a high rate episode for approximately one hour before passing out and requiring an external shock.Upon review of the transmission it was noted that the cardiac resynchronization therapy defibrillator (crt-d) withheld therapy for a ventricular tachycardia (vt) episode which was detected as supra ventricular tachycardia (svt).The device is still 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: 10733546
• MDR Text Key: 213007908
• Report Number: 3004209178-2020-18645
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169543362
• UDI-Public: 00643169543362
• 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: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2018
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Date Device Manufactured: 04/18/2017
• 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: 459888 LEAD, 6935M62 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 87 YR
• Patient Weight: 109