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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD WIDE SPACING, 92 CM; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD WIDE SPACING, 92 CM; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458QL/92
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Death (1802); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Seizures (2063); Shock (2072); Cardiac Tamponade (2226); Complaint, Ill-Defined (2331); Pericardial Effusion (3271)
Event Date 03/03/2018
Event Type  Death  
Event Description
It was reported that the patient presented to the emergency room after experiencing chest pain and flu-like symptoms for 3 days.Physical exam noted the patient's skin was pale, clammy, and the patient experienced fatigue and shock.An echocardiogram was performed which noted a moderate pleural effusion and tamponade.The patient became hypotensive, unresponsive, and required cpr.During cpr, an emergent pericardiocentesis was performed.An intravascular cooling device was placed.Seizure-like activity was noted.The patient remained intubated and multiple organ failure was observed.The implanted system was disabled.Later, on (b)(6) 2018 the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is cardiogenic shock.
 
Manufacturer Narrative
The damage found was sustained during the surgical procedure.The lead was otherwise normal.
 
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Brand Name
QUARTET LEAD WIDE SPACING, 92 CM
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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7379969
MDR Text Key103771835
Report Number2017865-2018-04543
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/07/2018
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 Expiration Date08/31/2020
Device Model Number1458QL/92
Device Catalogue Number1458QL/92
Device Lot NumberA000045218
Other Device ID Number05414734510226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/05/2018
Initial Date FDA Received03/28/2018
Supplement Dates Manufacturer Received03/28/2018
06/01/2018
Supplement Dates FDA Received03/28/2018
06/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2017
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) Death; Hospitalization; Life Threatening; Required Intervention;
Patient Age54 YR
Patient Weight94
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