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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD OPTISENSE; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC., CRMD OPTISENSE; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1999/52
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2013
Event Type  malfunction  
Event Description
It was reported that during implant, the stylet could not be advanced into the lead.After several attempts to reposition the lead, the lead was explanted and replaced.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.Device evaluation anticipated, but not yet begun.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
OPTISENSE
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
cary lawler
15900 valley view court
sylmar, CA 91342
8184932621
MDR Report Key3555761
MDR Text Key4100726
Report Number2017865-2014-00691
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2016
Device Model Number1999/52
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2013
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/25/2013
Event Location Hospital
Date Manufacturer Received11/25/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
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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