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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 Problems Kinked (1339); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during implant, the atrial lead would become kinked, would not retain its shape and was unable to be positioned.The lead was not used and a new lead was implanted.The patient was stable.
 
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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 Key5471768
MDR Text Key39428396
Report Number2017865-2016-01234
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 12/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
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 Number1944/52
Device Lot NumberA000008432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2015
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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