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

Model Number	DTMC1QQ
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: 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
• MDR Report Key: 8191444
• Report Number: 3004209178-2018-28262
• Device Sequence Number: 2118391
• Product Code: NIK
• UDI-Device Identifier: 00643169929715
• UDI-Public: 00643169929715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: DTMC1QQ
• Device Catalogue Number: DTMC1QQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6947M55 LEAD, 429888 LEAD, 5076-45 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 64 YR