Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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., CRMD ASSURITY PLUS DR RF; 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., CRMD ASSURITY PLUS DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2260
Device Problem No Device Output (1435)
Patient Problems Syncope (1610); Cardiac Arrest (1762)
Event Date 07/24/2014
Event Type  malfunction  
Event Description
It was reported that asystolic episodes were recorded while autocapture was on and the dependent patient experienced syncope.The pulse generator exhibited loss of output with no backup pulse delivered.The device was reprogrammed and remained implanted.Following the event, the patient was fine.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASSURITY PLUS DR RF
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jennie hamel
15900 valley view court
sylmar, CA 91342
8184933462
MDR Report Key4073762
MDR Text Key4899236
Report Number2017865-2014-16758
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2015
Device Model NumberPM2260
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-