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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 11/15/2023
Event Type  malfunction  
Event Description
During an in-clinic follow-up, the battery voltage trend on the device was unavailable.Abbott technical support was contacted and noted a battery longevity anomaly occurred.No intervention was performed at this time.The patient was stable and will continue to be monitored.
 
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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 Key18242483
MDR Text Key329428646
Report Number2017865-2023-93586
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeIT
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 Other Health Care Professional
Type of Report Initial
Report Date 11/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2017
Device Model NumberPM2162
Device Lot NumberP000023499
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
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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