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 Problems Premature Discharge of Battery (1057); Output Problem (3005)

Patient Problem Dyspnea (1816)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 383069, product type: lead, implanted (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the his bundle lead exhibited high pacing thresholds that significantly reduced battery longevity of the cardiac resynchronization therapy defibrillator (crt-d).The device was reprogrammed from a bi-ventricular (bi-v) pacing mode to pacing only in the right ventricle which increased remaining longevity.The patient reportedly experienced breathlessness during the overnight and returned the next day.When interrogating the device to program back to bi-v pacing, longevity was noted to be the same as prior to the programming change.When reprogramming was completed, longevity had been further reduced.The device was interrogated again and remaining longevity had returned to levels seen prior to any programming changes.The crt-d and lead remain in use.No further 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: 10544160
• MDR Text Key: 207289480
• Report Number: 3004209178-2020-16096
• 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: 09/16/2020

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: 12/28/2020
• 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: 08/27/2020
• Initial Date FDA Received: 09/16/2020
• Date Device Manufactured: 07/10/2019
• 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): Required Intervention
• Patient Age: 69 YR