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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
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ABBOTT AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE Back to Search Results
Model Number LSP112V
Device Problem Pacing Problem (1439)
Patient Problem Arrhythmia (1721)
Event Date 02/28/2024
Event Type  malfunction  
Event Description
It was reported that the patient presented in clinic with complaints of palpitations.Upon investigation, the pacing rate response was too high for the patient and the event was reproduced during testing.The device was reprogrammed to resolve the event and the patient was in stable condition.
 
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Brand Name
AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE
Type of Device
Leadless pacemaker
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18969894
MDR Text Key338503193
Report Number2017865-2024-35802
Device Sequence Number1
Product Code PNJ
UDI-Device Identifier05415067034472
UDI-Public05415067034472
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
P150035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLSP112V
Device Lot NumberS000091361
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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