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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3212
Device Problems Failure to Interrogate (1332); Pacing Intermittently (1443)
Patient Problem Syncope/Fainting (4411)
Event Date 02/18/2021
Event Type  Injury  
Event Description
The patient presented to the hospital with episodes of syncope.The event was unable to be interrogated.The physician suspected the device had reached normal end of life (eol), therefore the device was pacing intermittently causing syncope.The device was explanted and replaced to resolve the event.The patient was in stable condition.
 
Manufacturer Narrative
The pacer was received with battery levels at eol.Analysis performed with a new battery, indicated normal device functionality.The implant duration exceeds the projected longevity based on average monthly current indicating normal battery depletion.
 
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Brand Name
ANTHEM RF CRT-P
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key11529520
MDR Text Key241058750
Report Number2017865-2021-11614
Device Sequence Number1
Product Code NKE
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
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2013
Device Model NumberPM3212
Device Lot Number3537703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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