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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem Failure to Capture (1081)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  malfunction  
Event Description
During an in-clinic follow up, loss of capture was noted on both the right ventricular (rv) and left ventricular (lv) channels.The physician does not believe that the cause of the event was due to the leads.The device was reprogrammed to resolve the event.The patient was stable with no consequences.
 
Event Description
During an in-clinic follow up, loss of capture was noted on both the right ventricular (rv) and left ventricular (lv) channels during the capconfirm test.The physician does not believe that the cause of the event was due to the leads.The device was reprogrammed to resolve the event.The patient was stable with no consequences.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
QUADRA ALLURE MP CRT-P
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key11301606
MDR Text Key231006762
Report Number2017865-2021-07172
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510097
UDI-Public05414734510097
Combination Product (y/n)N
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000068808
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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