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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ALLURE QUADRA RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ALLURE QUADRA RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3242
Device Problem Failure to Interrogate (1332)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported during a remote merlin transmission session, the pacemaker lost communication with the radio frequency telemetry when measuring the remaining battery capacity.The patient visited the clinic and the pacemaker was restored to communicating with normal radio frequency telemetry function by reinterrogation.The patient condition is stable.
 
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Brand Name
ALLURE QUADRA RF CRT-P
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jaime chavez
645 almanor avenue
sunnyvale, CA 94085
8184934022
MDR Report Key5928632
MDR Text Key53941214
Report Number2938836-2016-10948
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P970013
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 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2016
Device Model NumberPM3242
Device Lot Number4917606
Was Device Available for Evaluation? No
Date Manufacturer Received07/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2014
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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