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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ENDURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT ENDURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2172
Device Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2022
Event Type  malfunction  
Event Description
It was reported the patient presented in the emergency room, upon interrogation it was noted the device was in back up mode.Technical support was contacted and recommended reprogramming to resolve the event.The device was reprogrammed.The patient was stable.
 
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Brand Name
ENDURITY 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 Key15979189
MDR Text Key307090807
Report Number2017865-2022-48682
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509602
UDI-Public05414734509602
Combination Product (y/n)N
Reporter Country CodeFI
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 12/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model NumberPM2172
Device Catalogue NumberPM2172
Device Lot NumberP000142091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2022
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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