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) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
  • 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) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3231-40Q
Medical Device Problem Code Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event or Problem Description
It was reported that a patient presented via remote transmission.Upon review, the implantable cardioverter defibrillator exhibited backup vvi mode and was at normal elective replacement indicator.The physician explanted and replaced the device.The patient was in stable condition.
 
Additional Manufacturer Narrative
The implantable cardioverter defibrillator was received for the reported event of backup vvi mode.The device was at normal elective replacement indicator (eri) and there was no indication the device ever entered backup vvi mode.No anomalies were noted.The reported event was unconfirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIFY CRT-D
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key8766097
Report Number2017865-2019-10567
Device Sequence Number13963184
Product Code NIK
UDI-Device Identifier05414734504393
UDI-Public05414734504393
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
P030054
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/14/2020
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 Date03/31/2012
Device Model NumberCD3231-40Q
Device Catalogue NumberCD3231-40Q
Device Lot Number3227877
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/22/2019
Supplement Date Received by Manufacturer04/03/2020
Initial Report FDA Received Date07/07/2019
Supplement Report FDA Received Date04/14/2020
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;
-
-