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

Model Number DTBB1QQ

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Shock from Patient Lead(s) (3162)

Event Date 05/06/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was potentially shocked for atrial fibrillation (af) with rapid ventricular response that was detected as ventricular tachycardia (vt).The cardiac resynchronization therapy defibrillator (crt-d) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was shocked by the cardiac resynchronization therapy defibrillator (crt-d) for atrial fibrillation (af) with rapid ventricular response that was detected as ventricular tachycardia (vt).The patient was admitted to the intensive care unit (icu).It was noted that the patient had not taken their antiarrhythmic medication for at least two weeks.The rhythm was also able to be terminated with atrial and ventricular anti-tachycardia pacing.The patient's physician did want the patient to receive therapy for the rhythm as the patient was doing poorly with it.The cardiac resynchronization therapy defibrillator (crt-d) feature designed to withhold inappropriate ventricular detection if the rhythm displays characteristics of supra ventricular tachycardia (svt) origin was turned off as the physician did not want therapy withheld.The patient never left the icu and expired of respiratory arrest approximately two weeks later.No further information was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received anti-tachycardia pacing and shocks from the cardiac resynchronization therapy defibrillator (crt-d) for atrial fibrillation (af) with rapid ventricular response that was detected as ventricular tachycardia (vt).The patient was admitted to the intensive care unit (icu).It was noted that the patient had not taken their antiarrhythmic medication for at least two weeks.The rhythm was also able to be terminated with atrial and ventricular anti-tachycardia pacing.The patient's physician did want the patient to receive therapy for the rhythm as the patient was doing poorly with it.The cardiac resynchronization therapy defibrillator (crt-d) feature designed to withhold inappropriate ventricular detection if the rhythm displays characteristics of supra ventricular tachycardia (svt) origin was turned off as the physician did not want therapy withheld.The patient never left the icu and expired of respiratory arrest approximately two weeks later.No further information was reported.

• Brand Name: VIVA QUAD S CRT-D
• 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: 10136992
• MDR Text Key: 194623920
• Report Number: 3004209178-2020-10015
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007161
• UDI-Public: 00643169007161
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2017
• Device Model Number: DTBB1QQ
• Device Catalogue Number: DTBB1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• Date Device Manufactured: 04/14/2016
• 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: 429888 LEAD, 6935M62 LEAD, 5076-52 LEAD
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 74 YR
• Patient Weight: 115