MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVO MRI SURESCAN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number RVDR01

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Electromagnetic Interference (1194); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that patient's blood pressure was low.It was also reported that during an arteriovenous fistula surgery the implantable pulse generator (ipg) exhibited oversensing, loss of pacing and loss of capture , coincident with the use of cautery.The ipg was subsequently tested in the post-anesthesia care unit and no abnormalities were observed.The ipg remains in use. no patient complications have been reported as a result of this event.

• Brand Name: REVO MRI SURESCAN
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 12279581
• MDR Text Key: 265144299
• Report Number: 3004209178-2021-11939
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2013
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Date Device Manufactured: 03/12/2012
• 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 Age: 80 YR
• Patient Weight: 101