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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC EUROPE SARL PROTECTA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number D314VRG
Medical Device Problem Code Failure to Charge (1085)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/24/2019
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 that the implantable cardioverter defibrillator (icd) exhibited an alert due to charge circuit timeout.The device had reached recommended replacement time (rrt) roughly two years prior and the patient refused explant of the device.The icd remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
PROTECTA XT VR
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH  1131
MDR Report Key9355485
Report Number9614453-2019-03926
Device Sequence Number11425114
Product Code LWS
UDI-Device Identifier00613994678164
UDI-Public00613994678164
Combination Product (Y/N)N
Initial Reporter StateME
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date04/14/2012
Device Model NumberD314VRG
Device Catalogue NumberD314VRG
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/28/2019
Initial Report FDA Received Date11/21/2019
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
7122 LEAD
Patient Age65 YR
Patient Weight122
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