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

Model Number	D284TRK
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Protective Measures Problem (3015)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Shock from Patient Lead(s) (3162)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: 419488 lead, (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient heard a "boom" and began to shake in their chair.It was noted a beeping sounds was also heard.Follow up yielded no information.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAXIMO II CRT-D
• Common Device Name: 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
• MDR Report Key: 7891352
• Report Number: 3004209178-2018-21055
• Device Sequence Number: 11389735
• Product Code: NIK
• UDI-Device Identifier: 00613994446916
• UDI-Public: 00613994446916
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 08/14/2013
• Device Model Number: D284TRK
• Device Catalogue Number: D284TRK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 77 YR