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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC EUROPE SARL PROTECTA XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number D314DRG
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/14/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2003.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during a device changeout due to normal battery depletion, the physician noted how easy the atrial lead came out of the device header.The same thing occurred with the defibrillation lead pins.The physician did not loosen the setscrews at all.Historical data were reviewed, with no setscrew warnings noted and consistent impedance values.The device was explanted and replaced.No patient complications have been reported as a result of this event.
 
Additional Manufacturer Narrative
Evaluation summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PROTECTA XT DR
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 Key8315871
Report Number9614453-2019-00402
Device Sequence Number18847655
Product Code LWS
UDI-Device Identifier00613994678188
UDI-Public00613994678188
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/22/2019
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
Operator of Device Lay User/Patient
Device Expiration Date02/28/2012
Device Model NumberD314DRG
Device Catalogue NumberD314DRG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Initial Date Received by Manufacturer 01/14/2019
Supplement Date Received by Manufacturer02/21/2019
Initial Report FDA Received Date02/07/2019
Supplement Report FDA Received Date02/22/2019
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
694765 LEAD
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