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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 (CRT-P)

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MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number W4TR04
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Mechanical Problem (1384); Capturing Problem (2891)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 479888 lead, implanted: (b)(6) 2021. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was high undefined pacing impedance on the right ventricular (rv) lead. The physician considered replacing the lead as a lead fracture or loose pin could not be confirmed by an x-ray. At a pre-procedure check, a noise-like event was confirmed and the threshold increased on the rv lead. During the procedure the device was removed and a loose pin was not confirmed. The rv lead was removed from the header and examined, the impedance and threshold were noted to be normal. Movement of the rv setscrew was visually confirmed, however, there was no problem with the setscrew itself. When the rv lead was connected back to the device, there was no issue with the impedance and threshold values. It was noted that the setscrew may not have been initially set properly. The physician chose to close the pocket and the device and lead remain 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 (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 Key12274658
MDR Text Key264976060
Report Number9614453-2021-03106
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
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received07/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/12/2020
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: 08/04/2021 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 5076-58 LEAD
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