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

Model Number DTMB1QQ

Device Problem Insufficient Information (3190)

Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Unspecified Infection (1930); Pneumonia (2011); Respiratory Distress (2045); Sepsis (2067); Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Failure (2484)

Event Date 05/19/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 5076-45 lead, implanted (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was admitted to the hospital with shortness of breath, hypotension and hypoxia.Decompensated pulmonary hypertension, congestive heart failure and sepsis were of specific concern.A chest x-ray showed gross fluid overload with concern for possible pneumonitis with opacity possibly representative of infection.Antibiotic treatment was initiated and the patient was given nebulizers due to concern of chronic obstructive pulmonary disease exacerbation.Diuretics were also administered.An electrocardiogram (ecg) showed concern for an unspecified failure of the cardiac resynchronization therapy defibrillator (crt-d).The patient was started on bi-level positive airway pressure and was switched to continuous positive airway pressure (cpap).Nasal high flow therapy was also administered.The patient could not be weaned off cpap due to continued respiratory distress and was suspected to have bacterial pneumonia.Although there was improvement in the patient¿s heart failure exacerbation, no improvement was seen in the patient¿s respiratory status despite an aggressive oral steroid regimen, inhaled steroids and supplemental oxygen.The subject was moved to comfort care four days after admission and died the same day.The final diagnosis was respiratory failure due to suspected bacterial pneumonia, brain death due to hypercapnia from respiratory failure, sepsis, pulmonary hypertension and acute on chronic combined heart failure.The patient was a participant in a clinical study.No further information was reported.

• Brand Name: AMPLIA 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: 10193033
• MDR Text Key: 196379484
• Report Number: 3004209178-2020-11002
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720671
• UDI-Public: 00643169720671
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2020
• Device Model Number: DTMB1QQ
• Device Catalogue Number: DTMB1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2020
• Date Device Manufactured: 03/18/2019
• 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
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 124