MAUDE Adverse Event Report: MEDTRONIC, INC. PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D354TRM

Device Problem Device Sensing Problem (2917)

Patient Problems Pneumonia (2011); Heart Failure (2206)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: a case of a cardiac resynchronization therapy-defibrillator exhibiting a lower and alternately variable basic rate.International heart journal.2018; 59(3):626-629.Doi: 10.1536/ihj.17-235.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding a patient with a cardiac resynchronization therapy-defibrillator (crt-d).The article reports three years after crt-d implantation, the patient was admitted to the hospital with pneumonia and exacerbation of heart failure.The patient developed atrial tachycardia (at) with a cycle length of 550-600 ms, which led to inadequate biventricular pacing in the programmed in ddi mode.In addition, the at was being under-sensed by the atrial lead.It was noted that the lengths of some cycles were observed to be longer than the programmed setting.Atrial pacing fell within the non-competitive atrial pacing (ncap) interval after his basic rate was reprogrammed to 100 beats/minute, thereby delaying atrial pacing to occur just after the ncap period.The device remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received through follow up which included the model number of the device.No further information was provided.

• Brand Name: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 7775061
• MDR Text Key: 116851409
• Report Number: 2182208-2018-01473
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D354TRM
• Device Catalogue Number: D354TRM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• 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: 67 YR