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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 Capture (1081)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 01/31/2017
Event Type  Injury  
Event Description
It was reported that when the patient presented in clinic after being transferred from another hospital, it was noted that the patient received four inappropriate shocks due to double counting rv pacing depolarization since the device was at maximum output. The previous hospital erased all the egms and there was no record to view. The patient has an icd implanted in the abdomen, and a pacemaker implanted in the left pectoral. Device was reprogrammed by the previous hospital. Analysis of the egms shows likely oversensing of pacing output. It was suspected that the pacemaker is likely tracking a sinus tachycardia, with conducted qrs's seen on the vf episode. The rv output was not capturing but was being sensed by the icd as well as intrinsic qrs. This was leading to diagnosis of vf and delivery of therapy. It was recommended to explant the pacemaker since there is the possibility of increased outputs during bvvi, as well as having two devices is contraindicated. Device was checked and is functioning normal now. Patient is doing fine.
 
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Brand NameALLURE QUADRA 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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6538030
MDR Text Key74206185
Report Number2938836-2017-23273
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
Type of Report Initial
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2016
Device Model NumberPM3242
Device Lot Number4795940
Other Device ID Number05414734507912
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 Received03/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
Treatment
(B)(4)
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