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

Model Number DTMA1QQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemothorax (1896); Pneumothorax (2012)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that post-operative to a cardiac resynchronization therapy defibrillator (crt-d) implant procedure, the patient experienced shortness of breath, chest pain, and hypotension; a pneumothorax was suspected however the chest x-ray was negative.During an echocardiogram, the patient became unresponsive, hypoxemic, hypotensive, and coded.The patient then recovered and a computerized tomography (ct) scan confirmed a left side hemothorax.Hypovolemic shock was noted, so a chest tube was placed to drain the hemothorax, but again the patient became hypotensive, so it was addressed with medicine.An angiogram confirmed a globular pseudo-aneurysm with arterial bleeding at the left anterior first rib.An arteriovenous fistula was embolized to resolution, the chest tube was removed, and the patient was to be treated medically.The following day, the left subclavian artery was repaired (stent grafts, thrombectomy) and a chest tube re-placed in the hemothorax, additional to a pleural catheter.The patient had continual shock and developed atrial fibrillation (af), which was successfully cardioverted; a repeat chest x-ray showed a new pneumothorax.The following day, the patient was extubated, and alert and responsive, but weak, showing only a stable small left apical pneumothorax.The device remains in use.The patient is a participant in the (b)(6) study.No further patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI QUAD 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8196152
• MDR Text Key: 131397435
• Report Number: 3004209178-2018-28333
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2020
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Date Device Manufactured: 08/08/2018
• 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: 6935M-55 LEAD, 4398-88 LEAD, 4076-45 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 66