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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2017
Event Type  Injury  
Event Description
New information states that the device was explanted and replaced on (b)(6) 2018. The patient was in a stable condition before, during and after the procedure.
 
Event Description
It was reported that an asymptomatic patient presented via remote transmission. Review of the transmission revealed noise reversion and several inappropriate auto mode switch episodes due to noise. The patient presented in clinic on (b)(6) 2017. The noise was reproducible on isometrics. Lead issue was suspected. Generator and lead replacement was discussed. No intervention was performed. The patient will continue to be monitored via remote transmission.
 
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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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key6985807
MDR Text Key107619628
Report Number2017865-2017-33798
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2011
Device Model NumberPM3210
Device Lot Number2870462
Other Device ID Number05414734503785
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2009
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: 10/27/2017 Patient Sequence Number: 1
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