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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA S DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA S DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number DDBC3D4
Medical Device Problem Code Pacing Problem (1439)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 04/15/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The patient's spouse reported that while the patient was in the hospital, the patient was noted to have a heart rate that was lower that the programmed rate.The implantable cardioverter defibrillator (icd) was indicated to not be "firing." the icd remains in use.No further patient complications have been reported as a result of this event.
 
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Brand Name
EVERA S DR
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key11864718
Report Number3004209178-2021-08143
Device Sequence Number17234930
Product Code LWS
UDI-Device Identifier00643169530294
UDI-Public00643169530294
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/21/2021
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 Date10/14/2018
Device Model NumberDDBC3D4
Device Catalogue NumberDDBC3D4
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2021
Initial Report FDA Received Date05/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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