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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX OPTIM LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX OPTIM LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1944/52
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 procedure the physician was unable to successfully implant the right atrial 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
ISOFLEX OPTIM LEAD
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 Key7184015
MDR Text Key97063730
Report Number2017865-2018-00598
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P960030
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 01/24/2018
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 Date11/30/2019
Device Model Number1944/52
Device Lot NumberP000039738
Other Device ID Number05414734502320
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2016
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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