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 Problem Defibrillation/Stimulation Problem (1573)

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

Event Date 10/29/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 479888 lead, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received an upgrade from a dual-chamber implantable cardioverter defibrillator (icd) to a cardiac resynchronization therapy defibrillator (crt-d).The day of the procedure, the patient was undergoing a fistulogram and went into respiratory arrest followed by ventricular tachycardia (vt)/ventricular fibrillation (vf).Cardiopulmonary resuscitation was performed.Upon interrogation of the device, it was noted there were multiple non-sustained episodes followed by an episode with six failed shocks.The right ventricular (rv) coil impedance was high on all therapies and the energy delivered from the device was.7 joules, however, the device was programmed to deliver 35 joules.A rv tip to rvcoil lead impedance warning had triggered and rv oversensing on stored electrograms (egm), along with intermittent atrial lead undersensing on the presenting egm were observed.The rv coil and pacing impedance when interrogated were observed to be high and the patient was transferred to the intensive care unit (icu).The patient was intubated and passed away the following day.

• 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: 9380745
• MDR Text Key: 168174502
• Report Number: 3004209178-2019-22715
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169837669
• UDI-Public: 00643169837669
• 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: 11/26/2019

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: 02/14/2021
• 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: 10/29/2019
• Initial Date FDA Received: 11/27/2019
• Date Device Manufactured: 08/27/2019
• 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: (B)(4) LEAD, (B)(4) LEAD
• Patient Outcome(s): Death
• Patient Age: 55 YR