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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR04
Device Problems Unable to Obtain Readings (1516); Communication or Transmission Problem (2896)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2012; 479888 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 pacemaker (crt-p) was implanted, and post patient evaluation revealed that the patient's atrial fibrillation (af) condition persisted after the procedure, therefore reactive anti-tachycardia pacing (atp) was set. Approximately four days later during the ward check it was found that the atrial fibrillation (af) episode information had disappeared. It was also noted an episode of atrial tachycardia (at)/af had been treated on the programmer, but there was no record on electrocardiogram (egm), and noted message that some arrhythmia episodes have invalid data. Approximately four days later, another device interrogation was performed, and again the egm could not be confirmed due to the previous noted missing data. A crt-p telemetry problem was also reported. An adjustment via ultrasound was performed. The crt-p remains in use. No patient complications have been reported as a result of this event.
 
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Brand NamePERCEPTA 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
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 Key10247993
MDR Text Key198076445
Report Number9614453-2020-02114
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Model NumberW4TR04
Device Catalogue NumberW4TR04
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 Received01/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2020
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: 07/08/2020 Patient Sequence Number: 1
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