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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 2088TC/52
Device Problems Device Sensing Problem (2917); High Capture Threshold (3266)
Patient Problem Dyspnea (1816)
Event Date 08/28/2020
Event Type  Injury  
Manufacturer Narrative

This product is registered as a combination product. 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 Description

It was reported that the patient experienced shortness of breath because the patient had been doing too much the day before and presented in clinic. Upon interrogation, it was noticed that the right ventricular (rv) threshold had risen and the r-wave had dropped. The physician elected to revise the lead. The patient was placed on the table, and the fluoroscope showed the rv lead to be positioned in the rv apex. The lead was successfully repositioned. The patient was stable.

 
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Brand NameTENDRIL STS
Type of DevicePERMANENT 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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key10475041
MDR Text Key205069701
Report Number2017865-2020-12603
Device Sequence Number1
Product Code NVN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2088TC/52
Device Catalogue Number2088TC-52
Device LOT NumberA000098942
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/15/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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