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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 W4TR01
Device Problem Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Event Description
It was reported that the left ventricular (lv) lead triggered an alert for a low pacing impedance. It was noted that the lv lead impedance was relatively stable, but was observed to drop below the alert threshold at times. It was also noted that the cardiac resynchronization therapy pacemaker (crt-p) triggered a later impedance alert in error. The lv lead and the crt-p remain in use. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: 5076-52 lead implanted: (b)(6) 2021. If information is provided in the future, a supplemental report will be issued.
 
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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 Key12780036
MDR Text Key280529658
Report Number9614453-2021-04223
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2021
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: 11/09/2021 Patient Sequence Number: 1
Treatment
5076-45 LEAD, 459888 LEAD
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