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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR

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ABBOTT FRONTIER II IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5596
Device Problems Pacemaker Found in Back-Up Mode (1440); Failure to Disconnect (2541); Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  Injury  
Event Description
It was reported that the device was observed to be in backup mode (bvvi). The suspected cause of the bvvi was due to normal end of life (eol), but normal battery depletion was unable to be confirmed by technical support. During the replacement procedure, the right atrial (ra) and right ventricular (rv) lead were unable to be removed from the device header. Additionally, when unscrewing the rv lead, a brown fluid was observed in the set screw of the device. The device was explanted and replaced to resolve the event. The patient was stable and will continue to be monitored.
 
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Brand NameFRONTIER II
Type of DeviceIMPLANTABLE 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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key11655671
MDR Text Key245102501
Report Number2017865-2021-15004
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2011
Device Model Number5596
Device Lot Number2914368
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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