MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D334VRM
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/27/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the spouse the patient died four years ago.It was also reported "the patient had pulse-less electrical activity, they were not sure if the device did or did not do what it was supposed to do, but the device did not shock the patient." a request for the circumstances and cause of death was made but not received.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.The cause of death was listed as cardiac arrest due to pulse-less electrical activity.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the physicians office.The cause of death was presumed to be pulse-less electrical activity (pea) and or hypotension, the implantable cardioverter defibrillator did not malfunction and there were no product problems.The circumstances surrounding the death were pea with normothermia protocol.

• Brand Name: PROTECTA VR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 7980573
• Report Number: 3004209178-2018-23400
• Device Sequence Number: 19228692
• Product Code: LWS
• UDI-Device Identifier: 00613994714626
• UDI-Public: 00613994714626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2018

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: 03/28/2014
• Device Model Number: D334VRM
• Device Catalogue Number: D334VRM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 10/30/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/30/2018; 11/06/2018
• 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: 6947M62 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR