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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
It was reported that the device was explanted and replaced as it is subject to the assurity and endurity pacemaker equipment anomaly advisory issued by abbott on 10 oct 2023 which applies to a subset of devices distributed and implanted outside of the united states.No malfunction was reported, and the patient is in stable condition with no adverse consequences.
 
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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 Key18251789
MDR Text Key329547341
Report Number2017865-2023-72516
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Model NumberPM2162
Device Lot NumberP000090059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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