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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that upon interrogation, the pulse generator exhibited loss of output.The device was reprogrammed.The patient was in good condition throughout the event.
 
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Brand Name
QUADRA ALLURE MP RF CRT-P
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 Key5918508
MDR Text Key54303706
Report Number2017865-2016-05706
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Model NumberPM3262
Device Lot NumberP000025800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/16/2016
Initial Date FDA Received08/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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