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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 Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2023
Event Type  Injury  
Event Description
It was reported that the longevity estimate observed on the device was incorrect.Abbott technical support was contacted and recommended reprogramming, which was performed 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 Key16615108
MDR Text Key312006585
Report Number2017865-2023-15703
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509572
UDI-Public05414734509572
Combination Product (y/n)N
Reporter Country CodeSP
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 Physician
Type of Report Initial
Report Date 03/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberPM1272
Device Catalogue NumberPM1272
Device Lot NumberP000139659
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2022
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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