• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ANTHEM RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT ANTHEM RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3212
Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383); No Pacing (3268)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  Injury  
Manufacturer Narrative
Implant/explant date is estimated to have occurred in 2013.
 
Event Description
It was reported that the device delivered an end of service (eos) alert on (b)(6) 2021. On (b)(6) 2022, the device delivered an elective replacement indicator (eri) and the patient experienced a loss of pacing. It was suspected that the initial eos alert was false and that there was possible premature battery depletion of the device. The device was explanted and replaced to resolve the event and the patient was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key13497776
MDR Text Key285333133
Report Number2017865-2022-02169
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2013
Device Model NumberPM3212
Device Lot Number3481636
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2011
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: 02/09/2022 Patient Sequence Number: 1
-
-