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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 1948/52
Device Problem Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a post op check, a kink was observed in the right ventricular lead.All electrical values were normal.The system was explanted on (b)(6) 2015 for unrelated reasons.
 
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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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key5480235
MDR Text Key39673699
Report Number2017865-2016-01282
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960030
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 12/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2018
Device Model Number1948/52
Device Lot NumberP000010648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age86 YR
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