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

Model Number DTMA1Q1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Fall (1848)

Event Date 08/16/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 693558 lead, implanted: (b)(6) 2018 5076-52 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with a cardiac resynchronization therapy defibrillator (crt-d) system is deceased.An allegation of device relatedness was noted by the patient's spouse.Additional information obtained reported that the patient was in the bathroom, had fallen off the toilet and was unresponsive.Emergency services was contacted, and the patient was brought to the emergency room where the patient died.The patient's spouse noted that the emergency room physician stated that the device "failed to work".It was further reported that the left ventricular (lv) lead exhibited a warning for measured low impedance about two months prior to the death.The cause of death was requested and not received.

Manufacturer Narrative

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

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: 9009849
• MDR Text Key: 157824121
• Report Number: 3004209178-2019-17513
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169929555
• UDI-Public: 00643169929555
• 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,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2019
• Device Model Number: DTMA1Q1
• Device Catalogue Number: DTMA1Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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: 439888 LEAD
• Patient Outcome(s): Death
• Patient Age: 65 YR