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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
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.
 
Event Description
It was reported a device check revealed a pacemaker was found in back up mode.The device was not used.
 
Manufacturer Narrative
The reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to a reset error had occurred and caused the device to revert to backup mode.Backup operation was reproduced at cold temperature, which is consistent with u2 xena ic cold temperature sensitivity anomaly.
 
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Brand Name
QUADRA ALLURE MP CRT-P
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key12041730
MDR Text Key257452231
Report Number2017865-2021-23720
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,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberA000104821
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/17/2021
Initial Date FDA Received06/22/2021
Supplement Dates Manufacturer Received10/07/2021
10/07/2021
Supplement Dates FDA Received10/07/2021
10/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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