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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 Signal Artifact/Noise (1036); Over-Sensing (1438); No Pacing (3268)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2019
Event Type  Injury  
Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that loss of pacing due to noise was observed on the device. The device was explanted and replaced to resolve the event. The patient was stable and there were no adverse consequences.
 
Manufacturer Narrative
Analysis of the device did not identify any mechanical or electrical malfunctions. Evaluation of the device header did not identify any anomalies that would have caused lead to device connection issues. A cross-talk/noise test was performed, and no noise was sensed by the device in the laboratory setting. Output monitoring and sensitivity testing verified that the device was sensing and pacing appropriately within specified limits. The device was received with battery voltage at end of service (eos) level and normal current consumption. Longevity assessment based on usage information found the battery depletion was normal.
 
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Brand NameANTHEM RF CRT-P
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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8819210
MDR Text Key151968303
Report Number2017865-2019-11310
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2014
Device Model NumberPM3212
Device Lot Number3862884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2012
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: 07/23/2019 Patient Sequence Number: 1
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