MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D334TRG

Device Problem Premature Discharge of Battery (1057)

Patient Problem Atrial Tachycardia (1731)

Event Date 03/01/2014

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room with symptomatic tachycardia.The patient was cardioverted successfully.Upon interrogation it was determined that the tachycardia was atrial in nature.The cardiac resynchronization therapy defibrillator (crt-d) was found to be at recommended replacement time (rrt) after only two years.The device did not meet longevity expectations.It was noted that there had been some programming changes seven months prior in which the outputs were set to high amplitude, and there was also a history of therapeutic charges.It was also reported that there was a complete loss of atrial sensing and no atrial pacing capture on the right atrial (ra) lead.There was no cardiac resynchronization therapy/ventricular pacing due to atrial undersensing, and the device was seeing r waves as premature ventricular contractions.There was also low pacing impedance on the ra lead, and noise on the ra electrogram.It was noted that there was a change in ra lead function after a coronary artery bypass graft seven months prior.In addition, there was no capture on the left ventricular (lv) lead.The lv lead showed previous insulation damage that had been significantly repaired.The device was reprogrammed to ventricular pacing and the device, ra lead, and lv lead were subsequently explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.Performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.

Manufacturer Narrative

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

• Brand Name: PROTECTA CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4314238
• MDR Text Key: 5207031
• Report Number: 3004209178-2014-23565
• Device Sequence Number: 1
• Product Code: NIK
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2014

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: 09/28/2012
• Device Model Number: D334TRG
• Device Catalogue Number: D334TRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided; 03/02/2015
• Supplement Dates FDA Received: 06/09/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2011
• 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: 5076-45 LEAD, 4194 LEAD, 6949 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00061 YR