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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1999/52
Device Problem Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during implant of the lead, the lead was difficult to position.The lead was removed from the pocket and a kink was found near the lead's tip.The lead was no longer used.
 
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Brand Name
OPTISENSE 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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5269472
MDR Text Key32863178
Report Number2017865-2015-30743
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P960013
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,Followup
Report Date 11/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2018
Device Model Number1999/52
Device Lot NumberP000006533
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2015
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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