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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 Problem Failure to Interrogate (1332)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  Injury  
Event Description
It was reported that the patient presented in clinic for follow up. Upon review, it was noted that the atrial and left ventricular lead were displaced. The patient presented for lead repositioning procedure. During preparation, physician noted that the pacemaker could not be interrogated via radio frequency (rf). A different programmer was used to interrogate but without success. The device was explanted and replaced, and both leads were repositioned on (b)(6) 2019. The procedure ended without further issues and the patient was discharged. Related manufacturer reference number: 2017865-2019-04522; related manufacturer reference number: 2017865-2019-04526.
 
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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 Key8467194
MDR Text Key140427525
Report Number2017865-2019-04520
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000062233
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2018
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: 03/29/2019 Patient Sequence Number: 1
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