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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 Electrical /Electronic Property Problem (1198)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330)
Event Date 11/17/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 1458q, lead, implanted: (b)(6) 2015. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced their cardiac resynchronization therapy pacemaker (crt-p) pacing in their abdomen which caused pain and discomfort. A crt-p feature, an automatic algorithm that monitors the pacing amplitude threshold and adjusts lead outputs, was turned off. The crt-p remains in use. No further 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 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 Key12631422
MDR Text Key276358435
Report Number9614453-2021-03978
Device Sequence Number1
Product Code NKE
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2021
Device Model NumberW4TR02
Device Catalogue NumberW4TR02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/07/2020
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: 10/14/2021 Patient Sequence Number: 1
Treatment
5086MRI52 LEAD, 5086MRI45 LEAD
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