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

Model Number 1944/52

Device Problems Incorrect Measurement (1383); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2020

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number- 2017865-2020-06682.Related manufacturer reference number-2017865-2020-06683.Related manufacturer reference number-2017865-2020-06685.It was reported that the patient developed an infection and presented in hospital with the device pocket red and swollen.Bacterial culture confirmed (b)(6) infection.The pacemaker was explanted, sterilized and disinfected and re-implanted.The atrial and right ventricular leads were explanted and replaced.During the operation on (b)(6) 2020, when implanting a new lead, the physician found abnormal sensing and impedance problem, the lead was replaced successfully.The patient was discharged.

Event Description

New information notes that parameters were unable to be measured for the new lead being implanted, on top of the aforementioned abnormal sensing and impedance problems.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: ISOFLEX OPTIM LEAD
• 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: 10103734
• MDR Text Key: 193032087
• Report Number: 2017865-2020-06686
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502320
• UDI-Public: 05414734502320
• Combination Product (y/n): N
• PMA/PMN Number: P960030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 1944/52
• Device Catalogue Number: 1944-52
• Device Lot Number: P000048524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISOFLEX OPTIM; ISOFLEX OPTIM; ZEPHYL XL DR
• Patient Age: 73 YR
• Patient Weight: 55