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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3210
Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081)
Patient Problems Arrhythmia (1721); Discomfort (2330)
Event Date 05/03/2021
Event Type  Injury  
Event Description
It was reported that the patient presented in the emergency room experiencing chest pain and arrhythmia, the patient's heart rate was at 40 beats per minute. Upon review, the pacemaker exhibited voltage less than that of the device's end of life showing premature battery depletion and as a result failed to capture the heart. The pacemaker was explanted and replaced. Patient was stable.
 
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Brand NameANTHEM RF CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key11871454
MDR Text Key252215587
Report Number2017865-2021-18897
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734503785
UDI-Public05414734503785
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2015
Device Model NumberPM3210
Device Catalogue NumberPM3210
Device Lot Number4347284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2013
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: 05/24/2021 Patient Sequence Number: 1
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