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 VICTORY 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 VICTORY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5810
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2013
Event Type  Injury  
Event Description
It was reported that the pulse generator exhibited premature battery depletion.The device was explanted.
 
Manufacturer Narrative
Device evaluation anticipated, but not yet begun.
 
Manufacturer Narrative
Analysis confirmed normal battery depletion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VICTORY 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
cary lawler
15900 valley view court
sylmar, CA 91342
8184932621
MDR Report Key3566720
MDR Text Key4056267
Report Number2017865-2014-03782
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
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2008
Device Model Number5810
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2013
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/15/2013
Device Age86 MO
Event Location Hospital
Date Manufacturer Received11/15/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-