• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL, INC. QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2018
Event Type  malfunction  
Event Description
During a device implant procedure, it was not possible to perform electrical measurements with the device as the lead was not able to be completely inserted into the header of the device. The device was replaced to resolve the event and the patient was stable.
 
Manufacturer Narrative
The reported device was received for evaluation. Analysis testing found is-4 test leads could be fully inserted into the lv-connector with normal insertion force. The lv-setscrew was tested to tighten down on the lead and the lead was held firmly in the connector by the setscrew. All connector dimensions were within specification. As received for testing nothing was found blocking the is-4 lead from inserting fully into the lv port. Normal device characteristics were found and there were no electrical anomalies. The battery voltage is above elective replacement indicator (eri) near beginning of life (bol).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8120033
MDR Text Key128900798
Report Number2017865-2018-18088
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSZ
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 01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberP000063340
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-