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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/46
Device Problems Difficult To Position (1467); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2013
Event Type  malfunction  
Event Description
It was reported that during the implant procedure, the physician had difficulty securely fixing the lead.The lead helix would retract on its own.The lead was not used and replaced.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.Evaluation description: analysis found normal device characteristics.
 
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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 Key3664398
MDR Text Key20109721
Report Number2017865-2014-10080
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2016
Device Model Number1888TC/46
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1888TC/46 CAC043336
Patient Age60 YR
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