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 SUSTAIN XL DR; 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 SUSTAIN XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2136
Device Problems No Device Output (1435); Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2014
Event Type  malfunction  
Event Description
It was reported that during pulse generator replacement, the device exhibited a loss of output.Interrogation revealed that the device went into backup vvi mode after suspected electrocautery interaction.The device was explanted and replaced.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUSTAIN XL DR
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 Key4073777
MDR Text Key21524540
Report Number2017865-2014-16786
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
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 Date06/30/2014
Device Model NumberPM2136
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-