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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 Device Operates Differently Than Expected (2913)
Patient Problem Fatigue (1849)
Event Date 01/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced fatigue.The device was tested in different modes and at different rates and delays but it failed everytime, diagnostics anomaly was noted.
 
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Brand Name
ALLURE RF
Type of Device
IMPLANTABLE 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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5429001
MDR Text Key37968020
Report Number2017865-2016-00839
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 company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Model NumberPM3222
Device Lot NumberA000011463
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age54 YR
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