MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADVISA MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number A2DR01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Congestive Heart Failure (1783); Death (1802)

Event Date 08/21/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: evolutpro-29-us transcatheter valve, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient family member that the patient suffered from congestive heart failure.It as noted that the physician increased the pacing of the implantable pulse generator (ipg).It was further reported that the patient passed away.Additional information related to the cause of death was requested and not received.

• Brand Name: ADVISA MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9088304
• MDR Text Key: 159188182
• Report Number: 3004209178-2019-17991
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169493377
• UDI-Public: 00643169493377
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• 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: 09/19/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: A2DR01
• Device Catalogue Number: A2DR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/19/2019
• 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: 407652 LEAD, 407645 LEAD
• Patient Outcome(s): Death
• Patient Age: 90 YR