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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 Difficult to Insert (1316)
Patient Problem Undesired Nerve Stimulation (1980)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that the patient presented to the hospital for an implant procedure.During the procedure, it was noted that the lead exhibited phrenic nerve stimulation then while loading the guidewire, the wire could not be inserted.The lead was not used and was replaced.The patient was in stable condition during and after the procedure.
 
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 Key10302383
MDR Text Key199691384
Report Number2017865-2020-09548
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,foreig
Type of Report Initial,Followup,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Model Number1458Q/86
Device Catalogue Number1458Q-86
Device Lot NumberA000086839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/01/2020
Initial Date FDA Received07/21/2020
Supplement Dates Manufacturer Received07/28/2020
08/21/2020
Supplement Dates FDA Received07/29/2020
08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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