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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1056T/86
Device Problem High Capture Threshold (3266)
Patient Problem Syncope (1610)
Event Date 07/17/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient presented to the hospital, the patient had a witnessed syncopal event in hospital that was captured on telemetry as loss of capture.This was confirmed on device interrogation.The lead was replaced.
 
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Brand Name
QUICKSITE LV
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5920615
MDR Text Key53678705
Report Number2017865-2016-05720
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2009
Device Model Number1056T/86
Device Lot Number2964296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2006
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;
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