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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 Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/26/2017
Event Type  malfunction  
Event Description
It was reported that during a device upgrade procedure the physician was unable to successfully implant the left ventricular lead.Several attempts were made without success.The lead was explanted and a new lead was implanted without issue.No additional information available.
 
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
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7184196
MDR Text Key97067869
Report Number2017865-2018-00600
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Model Number1458Q/86
Device Lot NumberS000019303
Other Device ID Number05414734503198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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