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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL SOLARA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR06
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the implant procedure, the device was implanted, and the leads were secured in the header. The post device insertion fluoroscopy suggested that the leads required some additional slack. The leads were removed from the header to allow them to be pushed into the vein further. Upon trying to reengage the setscrew to complete the lead fixation in the header, the setscrew could not be reengaged. The suspicion is that the set screws were back out too far and were lost and free under the grommet seal. When the wrench was re-inserted it traveled freely into the lead lumen through the open set screw hole. They could not dig the set screw out to reengage it. The device was attempted and not used. Another device was used to complete the procedure. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: 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
Product event summary: 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.
 
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Brand NameSOLARA QUAD 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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8292700
MDR Text Key134593002
Report Number9614453-2019-00326
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model NumberW4TR06
Device Catalogue NumberW4TR06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2018
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: 01/31/2019 Patient Sequence Number: 1
Treatment
5076-58, LEAD, 439888, LEAD.
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