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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL SERENA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W4TR02
Device Problem Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the left ventricular (lv) lead triggered an audible alert. Review of a remote transmission showed that the lv lead triggered an alert for low left ventricular (lv) lead impedance. No patient complications have been reported as a result of this event. No patient complications have been reported as a result of this event.
 
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Brand NameSERENA 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 PR 1131
SZ 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud PR 1131
SZ 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13841265
MDR Text Key287598815
Report Number2649622-2022-05283
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169891432
UDI-Public00643169891432
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/29/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2022
Device Model NumberW4TR02
Device Catalogue NumberW4TR02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2020
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: 03/21/2022 Patient Sequence Number: 1
Treatment
W4TR02 CRT-P, 5076-52 LEAD, 5076-58 LEAD
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