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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT TENDRIL STS; No Match
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ABBOTT TENDRIL STS; No Match Back to Search Results
Model Number 2088TC/52
Device Problems High impedance (1291); Capturing Problem (2891); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2024
Event Type  malfunction  
Event Description
During remote follow up, increased pacing impedance, decreased sensing and variable capture threshold were observed on the right atrial (ra) lead.No intervention has been performed.The patient was stable.
 
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Brand Name
TENDRIL STS
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key19047178
MDR Text Key339429795
Report Number2017865-2024-37693
Device Sequence Number1
Product Code NVN
UDI-Device Identifier05414734502887
UDI-Public(01)05414734502887(10)P000177025(17)260630
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
P960013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2088TC/52
Device Lot NumberP000177025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/04/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/31/2023
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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