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 Problems High impedance (1291); Mechanical Problem (1384); Device Contamination with Body Fluid (2317); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

Product event summary : the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The returned device indicated a loose/detached lv set screw.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular lead had rising and high threshold and decreased r waves.The lead was repositioned and remains in use.It was also reported that the device measured a rapid rise in left ventricular (lv) lead threshold and pacing impedance for vectors involving lv1.Coagulated blood was noted in the lv port, and when the lead was flushed and testing with the analyzer, the threshold and impedance were normal.As the lead was being re-inserted into the header, the set screw would not engage and the physician suspected the lead measurement issues were caused by a device header issue where blood entered the port.The device was explanted and replaced.No 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: 7255591
• MDR Text Key: 99558053
• Report Number: 3004209178-2018-02649
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169929562
• UDI-Public: 00643169929562
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2019
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0962-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR