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-SUNNYVALE) VERITY ADX XL; 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.(CRM-SUNNYVALE) VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5056
Medical Device Problem Code Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/31/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 the device was in backup vvi mode.The device was reset and programmed to normal pacing mode after contacting technical services.Battery life measured good parameters.The patient was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERITY ADX XL
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8346509
Report Number2938836-2019-01093
Device Sequence Number1923143
Product Code LWP
UDI-Device Identifier05414734006712
UDI-Public05414734006712
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/31/2018
Device Model Number5056
Device Lot NumberP000035053
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 01/31/2019
Initial Report FDA Received Date02/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-