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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problems Intermittent Capture (1080); Pacing Problem (1439); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
Analysis was normal. No anomalies were found.
 
Event Description
It was reported that the device exhibited error messages indicating abnormal pacing values and intermittent capture on the external monitor during a device implant procedure. Another device was used to complete the implant procedure. The new device behaved as expected. The patient was stable before, during and after the procedure.
 
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Brand NameQUADRA ALLURE MP RF CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7162246
MDR Text Key109067149
Report Number2938836-2018-00054
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberPM3262
Device Lot NumberA000039903
Other Device ID Number05414734509091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2017
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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