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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL SERENA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR05
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 383069, lead, implanted: (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient heard their cardiac resynchronization therapy pacemaker (crt-p) beeping. The crt-p was checked and it was observed that the crt-p displayed invalid trend data. The crt-p remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameSERENA 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
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10283245
MDR Text Key199089777
Report Number9614453-2020-02196
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 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2019
Device Model NumberW1TR05
Device Catalogue NumberW1TR05
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 Received06/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/09/2018
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: 07/16/2020 Patient Sequence Number: 1
Treatment
5076-45 LEAD, 5076-52 LEAD
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