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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL SDX LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL SDX LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1688TC/40
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 05/25/2018
Type of Reportable Event Death
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that the patient has deceased.  there is no known allegation from a health care professional that suggests that the death was device related.  the cause of death was a ventricular tachycardia storm.  no additional information was reported.
 
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Brand Name
TENDRIL SDX LEAD
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key7627745
Report Number2017865-2018-09165
Device Sequence Number1383733
Product Code NVN
UDI-Device Identifier05414734504812
UDI-Public05414734504812
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P960013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/30/2008
Device Model Number1688TC/40
Device Lot Number0002165423
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2018
Initial Report FDA Received Date06/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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