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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. REVO MRI SURESCAN; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. REVO MRI SURESCAN; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE Back to Search Results
Model Number RVDR01
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Death (1802)
Date of Event 06/19/2020
Type of Reportable Event Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported by the patient's representative that the patient is deceased.The reporter queried why they weren't informed that the implantable pulse generator (ipg) "was not working".Follow up was initiated to determine the cause of death however no further information is available at this time.
 
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Brand Name
REVO MRI SURESCAN
Common Device Name
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10384815
Report Number3004209178-2020-13729
Device Sequence Number17005988
Product Code LWP
UDI-Device Identifier00643169493407
UDI-Public00643169493407
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P090013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/10/2020
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
Operator of Device Lay User/Patient
Device Expiration Date01/14/2018
Device Model NumberRVDR01
Device Catalogue NumberRVDR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2020
Initial Report FDA Received Date08/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
5076-45 LEAD, 5076-52 LEAD
Outcome Attributed to Adverse Event Death;
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