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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2018
Event Type  malfunction  
Event Description
It was reported that during implant procedure, the tip of the lv lead noted to be loose when the physician tried to pull out the stylet.The lead was removed and replaced.There was no consequence to the patient.The patient was stable before 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-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7215722
MDR Text Key98093968
Report Number2938836-2018-00784
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeIS
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 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Model Number1458Q/86
Device Lot NumberS000044217
Other Device ID Number05414734503198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2017
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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