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

Model Number LPA1200M/52

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, it was noted that the helix of the right ventricular (rv) lead was bent upon being deployed.The physician elected to remove and replace the rv lead to complete the procedure.The patient was in stable condition throughout.

Manufacturer Narrative

The reported event of ¿helix screw was bend upon deploying the lead¿ was confirmed.Final analysis found that as received, a complete lead was returned in one piece with the helix clogged with blood/tissue and was found bent consistent with procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.X-ray examination showed that the helix was bent consistent with procedural damage.The cause of the reported event was consistent with procedural damage.

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, it was noted that the helix of the right ventricle (rv) lead was damaged upon being deployed.The physician elected to remove and replace the rv lead to complete the procedure.The patient was in stable condition throughout.

Manufacturer Narrative

Correction: b5 and h6.

• Brand Name: TENDRIL MRI
• 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 Key: 18341766
• MDR Text Key: 330664048
• Report Number: 2017865-2023-94896
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734504621
• UDI-Public: 05414734504621
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2024

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 Number: LPA1200M/52
• Device Lot Number: P000183352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/17/2023
• Supplement Dates Manufacturer Received: 01/20/2024; 03/19/2024; 03/26/2024
• Supplement Dates FDA Received: 02/13/2024; 03/21/2024; 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 78 KG