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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SOLARA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL SOLARA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR03
Device Problem Mechanical Problem (1384)
Patient Problems Syncope (1610); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the left ventricular (lv) lead was exhibiting intermittent or complete loss of capture and high thresholds. The patient reportedly experienced syncope and asystole with long pauses noted. A procedure was planned to replace the cardiac resynchronization therapy defibrillator (crt-d) as there was thought to be a device header issue stemming from the recent implant. The right ventricular (rv) lead was tested via the analyzer during the procedure and tested normally; however, the lead exhibited intermittent or complete loss of capture when connected to the crt-d. The crt-d was replaced and normal rv and lv lead function was noted. The following day, intermittent loss of capture was again noted on the rv lead. The lead was capped and replaced. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The reported device was a cardiac resynchronization therapy pacemaker (crt-p) not a cardiac resynchronization therapy defibrillator (crt-d).
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed 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 NameSOLARA CRTP
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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 Key7665183
MDR Text Key113270944
Report Number9614453-2018-02500
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2019
Device Model NumberW1TR03
Device Catalogue NumberW1TR03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/05/2018 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 5076-58 LEAD, 429688 LEAD
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