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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 No Pacing (3268)
Patient Problem Arrhythmia (1721)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
Related manufacturer report number: 2017865-2021-38013. During a planned device replacement procedure, when the new device was placed into the pocket, episodes of asystole were noted. Device inhibition or a loss of output was suspected. The leads were disconnected from the device and retested showing adequate output. The leads were reconnected and the device functioned appropriately. It was also noted the right ventricular (rv) lead had previously noted episodes of noise. The rv lead was capped and a new rv lead was placed. The patient was stable.
 
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Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12909147
MDR Text Key281522505
Report Number2017865-2021-38012
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000124907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2021
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: 12/01/2021 Patient Sequence Number: 1
Treatment
TENDRIL ST
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