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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, CRMD TENDRIL ST; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, CRMD TENDRIL ST; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1888TC/46
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the stylet could not be inserted.Lead was replaced.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Evaluation description: visual inspection noted the lead was kinked near the connector pin.Stylet was slight restricted at kinked area during insertion test.
 
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Brand Name
TENDRIL ST
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, CRMD
15900 valley view ct.
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, CRMD
15900 valley view ct.
sylmar CA 91342
Manufacturer Contact
cary lawler
15900 valley view ct.
sylmar, CA 91342
8184932621
MDR Report Key4193564
MDR Text Key4978764
Report Number2017865-2014-04152
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2011
Device Model Number1888TC/46
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/06/2012
Device Age3 YR
Event Location Hospital
Date Manufacturer Received01/06/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2008
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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