MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7122Q/58

Device Problem Use of Device Problem (1670)

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

Event Date 12/19/2023

Event Type  Injury  

Event Description

Related manufacturing reference number: 2017865-2024-00648.Related manufacturing reference number: 2017865-2024-00649.It was reported that the patient presented for a follow-up in clinic.It was noted that the left ventricular (lv) lead had no capture and was stimulating the phrenic nerve unintentionally.The patient felt minor discomfort due to the phrenic nerve stimulation.A chest x-ray (cxr) performed showed that the lv lead was dislodged.Additionally, the cxr also showed the right atrial (ra) and right ventricular (rv) leads had no slack.The lv lead was explanted and replaced, while the ra and rv lead were repositioned successfully on (b)(6) 2023.The patient was stable throughout the procedure.

Event Description

Related manufacturing reference number:(b)(4).It was reported that the patient presented for a follow-up in clinic.It was noted that the left ventricular (lv) lead had no capture and was stimulating the phrenic nerve unintentionally.The patient felt minor discomfort due to the phrenic nerve stimulation.A chest x-ray (cxr) performed showed that the lv lead was dislodged, and the physician suspects the dislodgement was due to twiddlers syndrome.Additionally, the cxr also showed the right atrial (ra) and right ventricular (rv) leads had no slack.The lv lead was explanted and replaced, while the ra and rv lead were repositioned successfully on (b)(6) 2023.The patient was stable throughout the procedure.

Manufacturer Narrative

Corrected data: b5 updated to indicate the dislodgement was due to twiddlers syndrome.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18465655
• MDR Text Key: 332324964
• Report Number: 2017865-2024-00650
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734503174
• UDI-Public: 05414734503174
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P950022
• 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
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122Q/58
• Device Lot Number: A000141718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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
• Treatment: GALLANT HF
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male