MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. COMPIA MRI QUAD CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMC1QQ

Device Problems Failure to Deliver Shock/Stimulation (1133); Defibrillation/Stimulation Problem (1573)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's daughter questioned if the cardiac resynchronization therapy defibrillator (crt-d) was working properly.It was further reported that post-implant the patient was "feeling weird" and "felt little electrical pulses." the patient became concerned when the electrical pulses were no longer felt.The family member stated that a report indicated that the patient's heart had stopped and a shock occurred; however, the family alleges that no shock was provided.It was also reported that the patient's ejection fraction had initially improved, but has begun to decline.The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: COMPIA MRI QUAD CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 8191444
• MDR Text Key: 131221280
• Report Number: 3004209178-2018-28262
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169929715
• UDI-Public: 00643169929715
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

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: 02/28/2019
• Device Model Number: DTMC1QQ
• Device Catalogue Number: DTMC1QQ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/21/2018
• Date Device Manufactured: 09/13/2017
• 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: 6947M55 LEAD, 429888 LEAD, 5076-45 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR