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); Delayed Charge Time (2586)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an excessive charge and a circuit timeout was noted a year and a half after the cardiac resynchronization therapy defibrillator (crt-d) reached recommended replacement time (rrt).The patient was noted to have been non compliant to device follow up.The device remains in use and a replacement is scheduled.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The device was not returned for analysis; however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated high voltage capacitor charge time was longer than expected for a device at eri (elective replacement indicator).Analysis of the device memory indicated a charge circuit timeout.If information is provided in the future, a supplemental report will be issued.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8268677
• MDR Text Key: 133783483
• Report Number: 3004209178-2019-01481
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

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: 08/28/2012
• Device Model Number: D224TRK
• Device Catalogue Number: D224TRK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 01/26/2019
• Supplement Dates FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2011
• 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: 4524-53 LEAD, 7121 LEAD, 419478 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 86