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

Model Number D224TRK

Device Problem Failure to Interrogate (1332)

Patient Problems Syncope (1610); Bradycardia (1751); Complete Heart Block (2627)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 419488 lead, implanted: (b)(6) 2011; 407652 lead, implanted: (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room with complete heart block (chb) and an escape rate in the 20s, with the patient experiencing syncope.The device could not be interrogated, so it was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Evaluation summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8806962
• MDR Text Key: 151575251
• Report Number: 3004209178-2019-13868
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2019

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: 05/28/2012
• Device Model Number: D224TRK
• Device Catalogue Number: D224TRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 11/29/2019; 11/29/2019
• Supplement Dates FDA Received: 11/29/2019; 11/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2010
• 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: 693558 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR