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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 Problems Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient presented to the clinic with phrenic nerve stimulation on their left ventricular lead.Interrogation showed all vectors caused the stimulation which did not allow for capturing on the lead.The physician explanted and replaced the lead.The patient was stable throughout.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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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
MDR Report Key10600594
MDR Text Key208983415
Report Number2017865-2020-14445
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number1458Q/86
Device Catalogue Number1458Q-86
Device Lot NumberA000091400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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