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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) TRANSSEPTAL NEEDLE, BRK SERIES
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ST. JUDE MEDICAL, INC. (AF-MINNETONKA) TRANSSEPTAL NEEDLE, BRK SERIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Complete Heart Block (2627)
Event Date 12/04/2013
Event Type  Injury  
Event Description
Related manufacturer reference 3005188751-2014-00015, 3005188751-2014-00016.During a paroxysmal atrial fibrillation ablation procedure, the patient developed complete heart block.The patient had a pre-existing left bundle branch block prior to the start of the procedure.While the physician was performing a transseptal puncture with a brk transseptal needle and transseptal introducer, the patient developed complete heart block.A non-sjm catheter was placed in the right ventricle to provide emergency pacing while a temporary placing lead was placed.The patient was stable.
 
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Brand Name
TRANSSEPTAL NEEDLE, BRK SERIES
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
minnetonka MN
Manufacturer Contact
denise johnson, rn
177 east country road b
st. paul, MN 55117
6517564071
MDR Report Key3628914
MDR Text Key18623057
Report Number3005188751-2014-00014
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/31/2013
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/31/2013
Initial Date FDA Received01/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TWO UNKNOWN SJM TRANSSEPTAL INTRODUCERS
Patient Outcome(s) Required Intervention;
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