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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1056T/75
Device Problems Signal Artifact/Noise (1036); Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
Event Type  malfunction  
Manufacturer Narrative
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 there was noise seen on the atrial lead and the left ventricular lead as well.There was also concern for clavicle crush and abrasion on both leads.It was unknown if any action had been taken.The patient was stable.Related manufacturer reference number: 2017865-2021-07050.
 
Manufacturer Narrative
Correction: please retract this report 2017865-2021-07049.The incorrect lead was reported.
 
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Brand Name
QUICKSITE LV
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11297627
MDR Text Key230944793
Report Number2017865-2021-07049
Device Sequence Number1
Product Code OJX
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 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2008
Device Model Number1056T/75
Device Lot Number0002212213
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TENDRIL SDX LEAD; TENDRIL SDX LEAD
Patient Age87 YR
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