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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Septic Shock (2068); Shock (2072); Cardiogenic Shock (2262)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product(s): 6935m55 lead, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was admitted due to a systemic inflammatory response syndrome with an unclear source.Blood cultures were performed, which tested positive for staphylococcus aureus bacteremia.The patient underwent removal of the cardiac resynchronization therapy defibrillator (crt-d) system, and following the procedure (in the evening), the patient went into multifactorial shock (hemorrhagic, septic and cardiogenic).The patient was treated with intravenous antibiotics and remained hospitalized.The patient received a new crt-d system approximately two weeks following explant.The patient is a participant in the post approval clinical surveillance product surveillance registry.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.

• 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: 9151952
• MDR Text Key: 165304219
• Report Number: 3004209178-2019-18932
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2020
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Date Device Manufactured: 11/26/2018
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 70