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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ENDURITY PACEMAKER, DR, MRI RESTRICTED; implantable pacemaker Pulse-generator
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ABBOTT ENDURITY PACEMAKER, DR, MRI RESTRICTED; implantable pacemaker Pulse-generator Back to Search Results
Model Number PM2162
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2024
Event Type  malfunction  
Event Description
It was reported that a diagnostic anomaly was observed on the device prior to implant.The device was reprogrammed to clear the anomaly and not implanted to resolve the event.A new device was implanted and the patient was in stable condition.
 
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Brand Name
ENDURITY PACEMAKER, DR, MRI RESTRICTED
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 Key18602694
MDR Text Key334022921
Report Number2017865-2024-03244
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P880086
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 01/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPM2162
Device Lot NumberA000139465
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/10/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2023
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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