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

Model Number D224TRK

Device Problems Failure to Charge (1085); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Protective Measures Problem (3015)

Patient Problems Cardiac Arrest (1762); Shock from Patient Lead(s) (3162)

Event Date 07/08/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant products: 4194 lead implanted (b)(6) 2005.Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the data indicated the criteria for the right ventricular lead integrity alert were met.Analysis of the data indicated high voltage capacitor charge time was longer than expected for a device at eri (elective replacement indicator).Analysis of the data indicated a charge circuit timeout, the unexpected delivery of ventricular tachyarrhythmia therapy, and oversensing due to non-physiologic signals.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was found unresponsive after having received an appropriate defibrillation therapy.The patient was transported to the hospital in cardiac arrest.A magnet was applied to the cardiac resynchronization therapy defibrillator (crt-d) to suspend therapy but the device continued to shock per the electrophysiologist.The device was found to be at end of service (eos) with an excessive charge time and charge circuit timeout.No changes were planned and the device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: CONSULTA CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6923995
• MDR Text Key: 88756524
• Report Number: 3004209178-2017-21085
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00613994446626
• UDI-Public: 00613994446626
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2017

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: 09/14/2012
• Device Model Number: D224TRK
• Device Catalogue Number: D224TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2011
• 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
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 61 YR