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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX S LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX S LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1646T/58
Device Problems Kinked (1339); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2016
Event Type  malfunction  
Manufacturer Narrative
Udi (di): (b)(4).
 
Event Description
It was reported that the lead could not be positioned properly during implant.The lead was not implanted.Upon removal, a kink was observed.
 
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Brand Name
ISOFLEX S 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 Key5472446
MDR Text Key39430284
Report Number2017865-2016-01244
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
Report Date 02/22/2016
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 Date01/31/2018
Device Model Number1646T/58
Device Lot NumberA000000847
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2015
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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