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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL STS; NO MATCH Back to Search Results
Model Number 2088TC/52
Device Problems Over-Sensing (1438); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Further information was requested but not received.
 
Event Description
Related manufacturer reference number: 2017865-2024-00475.It was reported that the right ventricular (rv) lead exhibited noise.The rv lead was explanted and replaced.It was also observed that the right atrial (ra) lead was explanted and replaced, due to an unknown issue.The patient had no adverse consequences.
 
Event Description
New information received notes that the right ventricular lead (rv) lead was oversensing noise which led to pacing inhibition.The right atrial (ra) lead had a lead dislodgement during the explant procedure of the rv lead and also had noise oversensing which was seen via merlin.Net transmission.
 
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Brand Name
TENDRIL STS
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 Key18476905
MDR Text Key332453116
Report Number2017865-2024-00476
Device Sequence Number1
Product Code NVN
UDI-Device Identifier05414734502887
UDI-Public05414734502887
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 Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/29/2024
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? Yes
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model Number2088TC/52
Device Lot NumberA000093849
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/15/2023
Initial Date FDA Received01/09/2024
Supplement Dates Manufacturer Received01/09/2024
Supplement Dates FDA Received01/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2020
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
ASSURITY.
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient SexMale
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