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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3222
Device Problem Under-Sensing (1661)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2017
Event Type  malfunction  
Event Description
It was reported that a merlin. Net transmission revealed the right atrial lead and pulse generator exhibited undersensing. The left ventricular lead exhibited loss of capture. The patient was brought into the clinic and an x-ray was performed which revealed that the left ventricular lead had dislodged. The physician elected to increase the device output. The patient was asymptomatic and would continue to be monitored.
 
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Brand NameALLURE RF
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 Key6494248
MDR Text Key72841655
Report Number2017865-2017-02313
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Model NumberPM3222
Device Lot NumberA000003676
Other Device ID Number05414734507905
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 Received03/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2015
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: 04/14/2017 Patient Sequence Number: 1
Treatment
1258T/86, BLG044319; 1699TC/46, EN028053
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