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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 1458QL/86
Device Problems Difficult to Insert (1316); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2020
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 during initial implant, the guide-wire became stuck inside the lumen of the lead.The physician successfully implanted a different lead.There were no patient consequences throughout.
 
Manufacturer Narrative
Analysis conclusion: the damage found was sustained during the surgical procedure.The lead was otherwise normal.
 
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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 Key10111712
MDR Text Key193603521
Report Number2017865-2020-06909
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734510219
UDI-Public05414734510219
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
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Model Number1458QL/86
Device Catalogue Number1458QL/86
Device Lot NumberS000070292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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