MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVO MRI SURESCAN; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number RVDR01

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

Patient Problems Syncope (1610); Stroke/CVA (1770)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that they have experienced issues that "could be stroke related" such as "passing out".The implantable pulse generator (ipg) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported by the physician that there was no product performance issue with the implantable pulse generator (ipg) and the patient symptoms were not related to a product performance issue.

• Brand Name: REVO MRI SURESCAN
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 9172165
• MDR Text Key: 161715876
• Report Number: 3004209178-2019-19276
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00613994614742
• UDI-Public: 00613994614742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2013
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Date Device Manufactured: 09/20/2011
• 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: 5086MRI45 LEAD, 5086MRI52 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR