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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 Problem Telemetry Discrepancy (1629)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2015
Event Type  malfunction  
Event Description
New information noted that on (b)(6) 2018, the download was performed successfully and rf telemetry function was normal. The patient was asymptomatic.
 
Event Description
New information noted that the device was in an rf lockout again. There was only 1 merline. Net transmission in the last 5 months. The device had not recently been interrogated either. The patient was doing fine. The patient would follow-up.
 
Event Description
It was reported that the asymptomatic patient presented, and the pacemaker had consistently exhibited radio-frequency telemetry lockout. It was noted that the device exhibited loss of communication via merlin. Net transmission, and exhibited slow telemetry in-clinic. No intervention had been performed, and the patient would continue to be followed-up.
 
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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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6908294
MDR Text Key109275309
Report Number2017865-2017-32585
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,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2015
Device Model NumberPM3210
Device Lot Number4278847
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 Received04/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2013
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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