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.(CRM-SYLMAR) VICTORY XL SR; IMPLANTABLE PACEMAKER
  • 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.(CRM-SYLMAR) VICTORY XL SR; IMPLANTABLE PACEMAKER Back to Search Results
Model Number 5610
Medical Device Problem Code Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that an asymptomatic patient presented to a follow-up in-clinic with their pacemaker exhibiting backup vvi mode.It was suspected to be caused by the device reaching end of life.Device was explanted and replaced on (b)(6) 2020.Patient was stable after the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VICTORY XL SR
Common Device Name
IMPLANTABLE PACEMAKER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10632457
Report Number2017865-2020-14841
Device Sequence Number11420758
Product Code LWP
UDI-Device Identifier05414734009539
UDI-Public05414734009539
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/31/2011
Device Model Number5610
Device Catalogue Number5610
Device Lot Number3073256
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/18/2020
Initial Report FDA Received Date10/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-