MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO MAXIMO II VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D284VRC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
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 by a representative of the patient that an audible alert had been emitting from the patient's implantable cardioverter defibrillator (icd) for the past four weeks.The patient has been admitted to the intensive care unit (icu) and it was indicated the device was "failing".The icd remains in use.No patient complications have been reported as a result of this event.

• Brand Name: MAXIMO II VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 12108638
• Report Number: 3004209178-2021-10334
• Device Sequence Number: 4600668
• Product Code: LWS
• UDI-Device Identifier: 00613994446619
• UDI-Public: 00613994446619
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 12/28/2013
• Device Model Number: D284VRC
• Device Catalogue Number: D284VRC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/02/2021
• 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: 694758 LEAD,
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 43 YR