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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

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ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM Back to Search Results
Model Number 100014514
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/02/2018
Event Type  Injury  
Manufacturer Narrative
Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to bent and broken pins in the navlink connector assembly.It is unknown how the damage occurred.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.
 
Event Description
During preparation, with the patient intubated, there were bent and broken pins identified in the navlink connector on the amplifier.The amplifier was replaced and the procedure was continued after a delay of 45 minutes.There were no adverse consequences to the patient.
 
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Brand Name
ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
Type of Device
ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key7219561
MDR Text Key98241941
Report Number2184149-2018-00011
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 01/25/2018
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
Device Model Number100014514
Other Device ID Number05414734210713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/02/2018
Initial Date FDA Received01/25/2018
Date Device Manufactured04/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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