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

Model Number DTMA1D1

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 693565 lead, implanted (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited varying battery longevity estimates over the course of a few months.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: CLARIA MRI 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: 10506968
• MDR Text Key: 206099640
• Report Number: 3004209178-2020-15567
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169837676
• UDI-Public: 00643169837676
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2020
• Device Model Number: DTMA1D1
• Device Catalogue Number: DTMA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/09/2020
• Date Device Manufactured: 11/16/2018
• 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: 407652 LEAD, 419478 LEAD
• Patient Age: 84 YR