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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3222
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During a device replacement procedure, the lead was unable to be connected to the device header.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
 
Manufacturer Narrative
The reported event of failure to insert the left ventricular (lv) lead into the lv-connector was not confirmed.Analysis testing revealed that the is-1 test leads could be fully inserted into the lv-connector with normal insertion force.All connector dimensions were within specification.No device anomalies were revealed and the device was revealed to be electrically normal.The battery voltage is above elective replacement indicator (eri) near beginning of life (bol).
 
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Brand Name
ALLURE RF
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key10455392
MDR Text Key204410232
Report Number2017865-2020-12214
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734507905
UDI-Public05414734507905
Combination Product (y/n)N
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model NumberPM3222
Device Catalogue NumberPM3222
Device Lot NumberP000100882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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