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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 Problems Pacemaker Found in Back-Up Mode (1440); Telemetry Discrepancy (1629); Operating System Version or Upgrade Problem (2997)
Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)
Event Date 09/01/2017
Event Type  malfunction  
Event Description
It was reported that the patient presented in the emergency room experiencing phrenic nerve stimulation (pns) and discomfort. Upon interrogation, the patient's pacemaker was found in back-up vvi. An attempt to download a device restore from the engineering test page with the telemetry wand in several positions failed. The patient was sent home with the device still in back-up vvi and was told to stay in a position that minimized the pns. On (b)(6) 2017 attempts to restore the device with a different programmer failed. On (b)(6) 2017, the patient was brought to a different clinic, and with a different programmer, the device was successfully restored to original programming with no further pns. The patient was sent home in stable condition.
 
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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-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 Key6926793
MDR Text Key89713685
Report Number2017865-2017-32250
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
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberPM3262
Device Lot NumberA000039088
Other Device ID Number05414734509091
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 Received09/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2017
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: 10/07/2017 Patient Sequence Number: 1
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