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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC. (CRM-KISTA) QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1258T/86
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2015
Event Type  malfunction  
Event Description
It was reported that during implant of the left ventricular lead, a competitor's angioplasty wire was inserted and the curvature of the lead would not straighten as intended.The lead was no longer used a replacement lead was successfully implanted.
 
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Brand Name
QUICKFLEX MICRO LV LEAD
Type of Device
PERMANENT PACEMAKER ELECTRODE
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 Key5316571
MDR Text Key34739029
Report Number3010215456-2015-32970
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2016
Device Model Number1258T/86
Device Lot Number4188567
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2013
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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