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-KISTA) PROMOTE RF 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-KISTA) PROMOTE RF CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number 3213-36
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient received inappropriate shocks due to supraventricular tachycardia.Programming changes were made.Patient is stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROMOTE RF CRT-D
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (CRM-KISTA)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
ulla strindlund
box 7051
isafjordsgatan 15
kista SE-16-407
SW   SE-16407
4684744043
MDR Report Key5336192
MDR Text Key34735275
Report Number3010215456-2015-30029
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2011
Device Model Number3213-36
Device Lot Number2929279
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2009
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;
-
-