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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL DX; No Match
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL DX; No Match Back to Search Results
Model Number 1388T/58
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2024
Event Type  malfunction  
Event Description
Related mfr report number: 2017865-2024-34245.It was reported that a patient suspects there right ventricular (rv) lead is failing which is contributing to reduced longevity of their pacemaker (pm) battery.No changes or interventions were reported.The patient condition is not known.
 
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Brand Name
TENDRIL DX
Type of Device
No Match
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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18846573
MDR Text Key337071931
Report Number2017865-2024-34246
Device Sequence Number1
Product Code NVN
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2001
Device Model Number1388T/58
Device Lot Number0002340719
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/1999
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
GUI-4269 RA LEAD; QUARTET LV LEAD
Patient Age92 YR
Patient SexFemale
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