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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 CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problems Pacemaker Found in Back-Up Mode (1440); Communication or Transmission Problem (2896); No Pacing (3268)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2019
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that the patient presented on (b)(6) 2019 for implant procedure. Upon review, the pacemaker lost telemetry with the wand and went into backup vvi. Also, the pacemaker was intermittently pacing. The patient was pacer dependent. The pacemaker was not used and was replaced. There were no patient consequences reported.
 
Manufacturer Narrative
The reported field event of backup mode was confirmed in the laboratory due to review of device image. Device image analysis indicated data corruptions occurred that left the device in a wrong state. After resetting the power, device regained normal operation and backup mode was no longer reproduced. Original device image data was not available to help explain the issue that was reported from the field. As a result of this finding, abbott is performing further investigation.
 
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Brand NameQUADRA ALLURE MP 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
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8814329
MDR Text Key151848917
Report Number2017865-2019-11198
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030035
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 10/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberA000081442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2019
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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