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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL SOLARA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W1TR06
Device Problems Pacing Problem (1439); Unable to Obtain Readings (1516)
Patient Problems Non specific EKG/ECG Changes (1817); Dizziness (2194)
Event Date 03/04/2021
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 and his bundle lead had variable measurements since implant. It was noted that the rv lead had high threshold measurements. Over the weekend, the patient was in the intensive care unit (icu) and a pause was seen on telemetry that corresponded to the patient raising the arm above the head. The pause could not be duplicated in clinic with provocative arm movement. The patient also had vague symptoms of dizziness. It was noted that programming changes were made due to the rv thresholds having a wide variability and that the clinician would explore root causes into the rise in threshold measurements for the lv lead and rv lead. It was also noted that the rv lead had intermittent capture and loss of capture throughout the current electrograms (egm) and the recorded episodes. It was further noted that the cardiac resynchronization therapy pacemaker (crt-p) exhibited invalid trending data. Reprogramming was done again and the device, rv lead and lv lead remain in use. No further patient complications have been reported as a result of this event.
 
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Brand NameSOLARA 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 Key11541324
MDR Text Key241423871
Report Number9614453-2021-01104
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 foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
Device Model NumberW1TR06
Device Catalogue NumberW1TR06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2018
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: 03/22/2021 Patient Sequence Number: 1
Treatment
5076-58 LEAD, 3830-69 LEAD, 5076-52 LEAD
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