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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Muscle Stimulation (1412)
Event Date 09/09/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced muscle stimulation.The left ventricular lead was suspected of malfunction and was explanted and replaced.No patient symptoms were reported.
 
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Brand Name
QUARTET
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 Key5365302
MDR Text Key35917041
Report Number2017865-2016-00274
Device Sequence Number1
Product Code OJX
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
Report Date 12/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Model Number1458Q/86
Device Lot NumberA000002309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2015
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;
Patient Age35 YR
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