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 Death (1802); High Blood Pressure/ Hypertension (1908); Sepsis (2067); Septic Shock (2068); Pericardial Effusion (3271)

Event Date 08/27/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 6935m62 lead implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was admitted for hypotension, depressive disorder and possible sepsis with shock norepinephrine.It was noted that the patient had chronic renal failure and received hemodialysis.Due to the multisystem failure and the patient showing little improvement after receiving aggressive care, the patient chose to enter hospice care.The patient was exhibited decompensation due to severe pulmonary hypertension, a dilated inferior vena cava, and an increased pericardial effusion.It was noted that the sepsis source was unclear, but treatment for strept infantarius bacteremia was delivered.After being admitted to hospice care, the patient exhibited ascites and cirrhosis and received palliative frequent paracentesis.The patient passed away a few days after admittance to hospice.The patient is a participant in the (b)(6) clinical study.

• 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: 9643737
• MDR Text Key: 176857931
• Report Number: 3004209178-2020-02123
• 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
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2019
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• Date Device Manufactured: 01/29/2018
• 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
• Treatment: 429888 LEAD, 407645 LEAD
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 83