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

Model Number RVDR01

Device Problems Pacing Problem (1439); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Weakness (2145)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced tired legs and felt weak with walking.Inappropriate rate response was noted.The implantable pulse generator (ipg) was reprogrammed and remains in use.No further patient complications have been reported as a result of this event.

• 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: 9217519
• MDR Text Key: 163178749
• Report Number: 3004209178-2019-20102
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2012
• Device Model Number: RVDR01
• Device Catalogue Number: RVDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Date Device Manufactured: 04/19/2011
• 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: 5086MRI58 LEAD, 5086MRI52 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR