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

Model Number LPA1200M/58

Device Problems Capturing Problem (2891); Device Sensing Problem (2917)

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

Event Date 02/28/2024

Event Type  Injury  

Event Description

It was reported that the patient presented in the clinic for a follow-up.Upon interrogation, the right ventricular lead exhibited a high capture threshold and a decrease in r wave amplitude.Programming changes were made.The patient was stable and will continue to be monitored.

Event Description

New information received notes that the right ventricular lead was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events of high capture threshold and r-wave amp variation were not confirmed.Final analysis found that as received, a complete lead was returned in one piece for analysis.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies except for procedural damage.

• 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: 18922399
• MDR Text Key: 337882645
• Report Number: 2017865-2024-35214
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734504638
• UDI-Public: 05414734504638
• 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
• Report Date: 05/13/2024

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 Date: 08/31/2022
• Device Model Number: LPA1200M/58
• Device Lot Number: P000120042
• 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: 02/28/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/27/2024; 04/22/2024
• Supplement Dates FDA Received: 04/21/2024; 05/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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
• Treatment: LPA1200M/52 MRI TENDRILL; PM2272 ASSURITY
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male