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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SOLARA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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MEDTRONIC EUROPE SARL SOLARA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W4TR03
Device Problem Pacing Problem (1439)
Patient Problems Bradycardia (1751); Fall (1848)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that experienced a fall and emergency medical services (ems) reported that the patient was experiencing bradycardia. The heart rate was noted by ems to be approximately 30-40 beats per minute (bpm), which is below the lower programmed rate of 60 bpm for the cardiac resynchronization therapy pacemaker (crt-p). Review of the crt-p histograms noted no recorded rates below the lower programmed rate. The crt-p remains in use. No further patient complications have been reported as a result of this event.
 
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Brand NameSOLARA QUAD CRT-P MRI SURESCAN
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13870367
MDR Text Key288034272
Report Number9614453-2022-00859
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169891456
UDI-Public00643169891456
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 Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2021
Device Model NumberW4TR03
Device Catalogue NumberW4TR03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/26/2020
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: 03/23/2022 Patient Sequence Number: 1
Treatment
5076-58 LEAD, 5076-52 LEAD, 459888 LEAD
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