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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA¿ XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DDBB1D4
Medical Device Problem Code Failure to Capture (1081)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/09/2019
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
It was reported approximately seven months post implant the device is pacing but did not appear to be capturing.The device remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
EVERA¿ XT DR
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key9546765
Report Number3004209178-2020-00134
Device Sequence Number2334771
Product Code LWS
UDI-Device Identifier00643169929128
UDI-Public00643169929128
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 01/03/2020
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 Date05/28/2019
Device Model NumberDDBB1D4
Device Catalogue NumberDDBB1D4
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/09/2019
Initial Report FDA Received Date01/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age64 YR
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