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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 PM2272
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2022
Event Type  Injury  
Event Description
It was reported the device was in telemetry lockout.No intervention was performed to resolve the lockout.The device was explanted and replaced prophylactically as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on 20 july 2022, which applies to a subset of devices distributed and implanted outside of the united states.The patient was in stable condition.
 
Manufacturer Narrative
The reported event was the prophylactic explant of a device that was subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on (b)(6) 2022, which applies to a subset of devices distributed and implanted outside of the united states.The device was returned due to advisory with no allegation of a malfunction.Visual inspection of the device and header attachment area did not find any anomalies.Interrogation of the device indicated battery voltage and current within normal range when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).
 
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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 Key15719621
MDR Text Key302919113
Report Number2017865-2022-44055
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509589
UDI-Public05414734509589
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 12/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model NumberPM2272
Device Catalogue NumberPM2272
Device Lot NumberP000106237
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/25/2022
Initial Date FDA Received11/03/2022
Supplement Dates Manufacturer Received12/14/2022
Supplement Dates FDA Received12/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2020
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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