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

Model Number DTMA1Q1

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

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

Event Date 07/22/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 694765 lead, implanted (b)(6) 2008.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced an episode of ventricular fibrillation (vf) which looked like a combination of polymorphic ventricular tachycardia (vt) and vf.The vf was undersensed and the cardiac resynchronization therapy defibrillator (crt-d) reportedly did not detect the rhythm and deliver a shock until approximately nine minutes later at which time the patient was likely already deceased.The cause of death was apparent vf.The last known status of the lead which senses in the right ventricle and the crt-d was that they remained in the patient.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: 10405710
• MDR Text Key: 202853273
• Report Number: 3004209178-2020-14065
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169929555
• UDI-Public: 00643169929555
• 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: 08/13/2020

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: 11/28/2018
• Device Model Number: DTMA1Q1
• Device Catalogue Number: DTMA1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/13/2020
• Date Device Manufactured: 06/06/2017
• 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: 5076-52 LEAD, 429888 LEAD
• Patient Outcome(s): Death
• Patient Age: 75 YR