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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVO MRI SURESCAN; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE Back to Search Results
Model Number RVDR01
Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516); Missing Test Results (3267)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2019
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated an issue with missing/invalid diagnostic data.Analysis of the device memory indicated the battery measurement was not available.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implantable pulse generator (ipg) battery voltage was missing and trend measurements were not available and a bitflip was present.The ipg remains in use.No patient complications have been reported as a result of this event.
 
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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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8548967
MDR Text Key143056807
Report Number3004209178-2019-08232
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00613994614742
UDI-Public00613994614742
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P090013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/28/2013
Device Model NumberRVDR01
Device Catalogue NumberRVDR01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/27/2019
Initial Date FDA Received04/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
5086MRI45 LEAD, 5086MRI52 LEAD
Patient Age71 YR
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