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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD TENDRIL ST; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC., CRMD TENDRIL ST; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1888TC/58
Device Problems High impedance (1291); Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2014
Event Type  malfunction  
Event Description
It was reported that during the implant procedure, low impedance was observed on the right ventricular lead.Despite repositioning the lead several times, the issue remained.The lead was removed and the lead was noted to be kinked in two locations.A new lead was successfully implanted.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.
 
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Brand Name
TENDRIL ST
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 Key3797215
MDR Text Key4527108
Report Number2017865-2014-13079
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2016
Device Model Number1888TC/58
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2013
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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