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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

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MEDTRONIC EUROPE SARL PROTECTA VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number D364VRM
Device Problems High impedance (1291); High Sensing Threshold (2574); High Capture Threshold (3266)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the right ventricular (rv) lead exhibited high thresholds and high pacing impedances.The rv lead was explanted and replaced.Additionally, it was reported that the implantable cardioverter defibrillator (icd) had high thresholds.The icd was explanted and replaced.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PROTECTA VR
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH  1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH   1131
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7759526
MDR Text Key116719271
Report Number9614453-2018-02779
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P980016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/28/2014
Device Model NumberD364VRM
Device Catalogue NumberD364VRM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2018
Initial Date FDA Received08/07/2018
Supplement Dates Manufacturer Received09/12/2018
08/08/2018
Supplement Dates FDA Received09/20/2018
10/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age67 YR
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