MAUDE Adverse Event Report: ABBOTT TENDRIL SDX LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1688TC/52

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2022

Event Type  Injury  

Event Description

It was reported that oversensing was observed on the right ventricular (rv) lead and insulation damage was observed on the right atrial (ra) lead.During revision, diagnostic imaging showed a conductor fracture on the rv lead.The ra lead and rv lead were capped.The rv lead was successfully replaced with a new rv lead.The ra lead was not replaced due to patient condition.The patient was stable and there were no adverse consequences.Related manufacturer reference number: 2017865-2022-06583.

• Brand Name: TENDRIL SDX LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13941789
• MDR Text Key: 288136204
• Report Number: 2017865-2022-06584
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734501859
• UDI-Public: 05414734501859
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2009
• Device Model Number: 1688TC/52
• Device Catalogue Number: 1688TC-52
• Device Lot Number: 3036636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2006
• 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