MAUDE Adverse Event Report: ABBOTT TENDRIL ST; NO MATCH

Model Number 1888TC/52

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that the patient had syncope.High capture threshold and high pacing impedance were observed on the right ventricular (rv).Lead damage was suspected on the rv lead and the right atrial (ra) lead.The rv lead and ra lead were replaced to resolve the event.The patient was stable and there were no adverse consequences.Additional information was requested but was not available.Related manufacturer reference number: 2017865-2024-35688.

Event Description

It was reported that right atrial (ra) lead was explanted and replaced.The patient was stable and there were no adverse consequences.Additional information was requested but was not available.

Event Description

It was reported that the patient had syncope.High capture threshold and high pacing impedance were observed on the right ventricular (rv).Lead damage was suspected on the rv lead and the right atrial (ra) lead.The rv lead and ra lead were explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.Additional information was requested but was not available.

• Brand Name: TENDRIL ST
• 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 Key: 18964969
• MDR Text Key: 338428083
• Report Number: 2017865-2024-35689
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501750
• UDI-Public: 05414734501750
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2024

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 Expiration Date: 08/31/2014
• Device Model Number: 1888TC/52
• Device Lot Number: 3462720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/28/2024; Not provided
• Supplement Dates FDA Received: 04/12/2024; 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention