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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM1272
Device Problems Pacing Asynchronously (1441); Under-Sensing (1661)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2022
Event Type  malfunction  
Event Description
It was reported that undersensing lead to pacemaker mediated tachycardia was observed on the device.Abbott technical support was contacted and recommended reprogramming, which was anticipated to resolve the event.The patient was stable and there were no adverse consequences.
 
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Brand Name
ASSURITY MRI
Type of Device
IMPLANTABLE 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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key15936459
MDR Text Key306994740
Report Number2017865-2022-48049
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509572
UDI-Public05414734509572
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P140033
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 12/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Model NumberPM1272
Device Catalogue NumberPM1272
Device Lot NumberP000151173
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2022
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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