MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) TENDRIL MRI; PERMANENT PACEMAKER ELECTRODE

Model Number LPA1200M/52

Device Problems Difficult to Insert (1316); Use of Device Problem (1670)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.

Event Description

It was reported that during an initial implant, the guidewire could not be inserted fully into a lead.The lead could not be implanted.A new lead was used to complete the operation.No adverse consequences reported on the patient.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: TENDRIL MRI
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11279922
• MDR Text Key: 230297323
• Report Number: 2017865-2021-06072
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 05414734504621
• UDI-Public: 05414734504621
• Combination Product (y/n): N
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: LPA1200M/52
• Device Catalogue Number: LPA1200M-52
• Device Lot Number: P000105256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1