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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 Problem Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Event Description
During a routine device replacement procedure, it was noted there was difficulty removing the right ventricular (rv) lead from the header of the device. Firm pressure was applied and the rv lead was able to be removed from the device header. The device was replaced to resolve the event and the patient was stable.
 
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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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key11939550
MDR Text Key254287073
Report Number2017865-2021-18980
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2013
Device Model NumberPM3212
Device Lot Number3619796
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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