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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) PROMOTE QUADRA CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC. (CRM-KISTA) PROMOTE QUADRA CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3239-40Q
Device Problem Over-Sensing (1438)
Patient Problem Therapeutic Response, Increased (2272)
Event Date 10/02/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that pacemaker mediated tachycardia initiated by premature ventricular contraction and inappropriate auto mode switching episodes due to r-wave oversensing were observed.Programming changes were recommended.
 
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Brand Name
PROMOTE QUADRA 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 Key5487042
MDR Text Key40062825
Report Number3010215456-2016-00850
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 01/26/2016
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
Device Operator Health Professional
Device Expiration Date11/30/2012
Device Model NumberCD3239-40Q
Device Lot Number3401039
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2016
Initial Date FDA Received03/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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