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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

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MEDTRONIC EUROPE SARL SERENA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR05
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 5076 lead implanted: (b)(6) 2020; 4298 lead implanted: (b)(6) 2020. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited invalid trending data. The crt-d remains in use. 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
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 Key11108218
MDR Text Key224778673
Report Number9614453-2021-00003
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2021
Device Model NumberW4TR05
Device Catalogue NumberW4TR05
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 Received12/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/04/2020
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: 01/04/2021 Patient Sequence Number: 1
Treatment
4087 LEAD
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