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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1457Q/86
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2017
Event Type  malfunction  
Event Description
It was reported that during initial implant procedure, the left ventricular lead could not be delivered to the target vessel and be placed in a stable position.The lead was explanted and replaced.There were no adverse consequences.Patient was stable post procedure.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
QUARTET LEAD DOUBLE BEND, 86 CM
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 Key7119490
MDR Text Key94978727
Report Number2017865-2017-36089
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054/S314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Model Number1457Q/86
Device Lot NumberA000039435
Other Device ID Number05414734510189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
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